| 2025-11-24 |
Class II
|
Ongoing |
Z-0957-2026 |
BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener. |
— |
Removal of affected lot of screws due to labeling error. |
| 2025-03-18 |
Class II
|
Ongoing |
Z-1806-2025 |
META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690 |
— |
Integrated Lag/Compression Screw Kit has a compression screw with hexagon socket that may be undersized, which causes the screw to be non-functional, which woul… |
| 2024-10-29 |
Class II
|
Ongoing |
Z-0581-2025 |
BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor. |
— |
Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device. |
| 2024-10-15 |
Class II
|
Ongoing |
Z-0326-2025 |
Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femo… |
— |
The Bipolar assembly contains an oversized Retainer Ring. |
| 2024-10-02 |
Class II
|
Ongoing |
Z-0282-2025 |
smith&nephew LEGION OXINIUM POSTERIOR STABILIZED NONPOROUS FEMORAL COMPONENT, SIZE 5N, RIGHT, NARROW, REF 71421275; Unco… |
— |
Complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 5N RIGHT implant instead of a GENESIS II POSTERIOR STABILIZED FEMORAL SIZE 5 L… |
| 2024-10-02 |
Class II
|
Ongoing |
Z-0281-2025 |
smith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT, SIZE 5 LEFT, REF 71421015; Uncoated knee femur… |
— |
Complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 5N RIGHT implant instead of a GENESIS II POSTERIOR STABILIZED FEMORAL SIZE 5 L… |
| 2024-10-02 |
Class II
|
Ongoing |
Z-0278-2025 |
smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 4 LEFT, REF 71421164; PROSTHESIS, KNEE, PATELL… |
— |
Complaint received indicating that a package contained a LGN OX CONSTRAINED FEM 3 LT implant instead of a LGN OX CONSTRAINED FEM 4 LT as described on the produc… |
| 2024-10-02 |
Class II
|
Ongoing |
Z-0277-2025 |
smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 3 LEFT, REF 71421163; PROSTHESIS, KNEE, PATELL… |
— |
Complaint received indicating that a package contained a LGN OX CONSTRAINED FEM 3 LT implant instead of a LGN OX CONSTRAINED FEM 4 LT as described on the produc… |
| 2024-08-12 |
Class II
|
Ongoing |
Z-3097-2024 |
ROTATION MEDICAL TENDON STAPLES (8) (narrow indication)-Intended for fixation of prosthetic material to soft tissues. … |
— |
Product packaging process may result in an improper or incomplete seal of the outer foil pouch surrounding the inner Tyvek pouch, compromising product sterility |
| 2024-08-12 |
Class II
|
Ongoing |
Z-3096-2024 |
ROTATION MEDICAL TENDON STAPLES (8) (broad indication)-Intended for fixation of prosthetic material to soft tissues. Pr… |
— |
Product packaging process may result in an improper or incomplete seal of the outer foil pouch surrounding the inner Tyvek pouch, compromising product sterility |
| 2024-07-09 |
Class II
|
Ongoing |
Z-3172-2024 |
DIAMOND POINT, BOTH ENDS K-WIRE, REF 128062, metallic bone fixation fastener |
— |
Smith & Nephew, Inc., has initiated a field action to voluntarily remove two batches of K-Wires due to a packaging error. A complaint was received indicating th… |
| 2024-07-09 |
Class II
|
Ongoing |
Z-3171-2024 |
DIAMOND POINT, BOTH ENDS K-WIRE, REF 128042, metallic bone fixation fastener |
— |
Smith & Nephew, Inc., has initiated a field action to voluntarily remove two batches of K-Wires due to a packaging error. A complaint was received indicating th… |
| 2024-04-24 |
Class II
|
Ongoing |
Z-1901-2024 |
smith&nephew OXINIUM Femoral Head 12/14 Taper, REF 71343204, 32 MM OD +4, Sterile; and smith&nephew, 12/14 Taper, REF 71… |
— |
Packaging contained the incorrect size of femoral head from what was displayed on the label. |
| 2023-09-27 |
Class II
|
Ongoing |
Z-0158-2024 |
JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262; knee prosthesis |
— |
The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM. And also, a JRNY II BCS CNSTRD… |
| 2023-09-27 |
Class II
|
Ongoing |
Z-0157-2024 |
JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; knee prosthesis |
— |
The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM. And also, a JRNY II BCS CNSTRD… |
| 2023-08-31 |
Class II
|
Ongoing |
Z-2621-2023 |
smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, REF 71421265; knee j… |
— |
The firm conducting a recall due to a complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 4N LT implant instead of a LEGION NARROW… |
| 2023-07-24 |
Class II
|
Ongoing |
Z-2444-2023 |
TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT, REF 71647340, Femur nail |
— |
A complaint was received indicating that a package contained a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT implant instead of a TRIGEN… |
| 2023-07-24 |
Class II
|
Ongoing |
Z-2443-2023 |
TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71647336, Femur nail |
— |
A complaint was received indicating that a package contained a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT implant instead of a TRIGEN… |
| 2023-05-02 |
Class II
|
Ongoing |
Z-1673-2023 |
Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Insert, Part Numbers: a) REF 1-10013-109, SIZE 1-LE… |
— |
Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The dat… |
| 2023-05-02 |
Class II
|
Ongoing |
Z-1672-2023 |
Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Tray, Part Numbers: a) REF 1-10012-100, SIZE 1-LEFT M… |
— |
Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The dat… |
| 2023-05-02 |
Class II
|
Ongoing |
Z-1671-2023 |
Smith&Nephew ENGAGE Cementless Partial Knee System, Tibial Anchor Stem, Part Numbers: a) REF 1-10011-100 (SIZE 1-2), b… |
— |
Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The dat… |
| 2023-05-02 |
Class II
|
Ongoing |
Z-1670-2023 |
Smith&Nephew ENGAGE Cementless Partial Knee System, Porous Femoral components, Part Numbers: a) REF 1-10003-100 (SIZ… |
— |
Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The da… |
| 2023-03-27 |
Class II
|
Ongoing |
Z-1393-2023 |
JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM |
— |
A mispack occurred during the manufacturing process, resulting in the box incorrectly containing JOURNEY II UNI Tibia Insert Medical Size 1-2 12MM instead of th… |
| 2022-06-27 |
Class II
|
Terminated |
Z-1418-2022 |
(1) Genesis II Non-Porous Tibial Baseplate Size 5 Right, Product #71420186. (2) Genesis II Non-Porous Tibial Baseplate … |
— |
The product was mispackaged (swapped). The devices within the inner tray matches the inner tray but does not match the outer box label and the chart sticks. |
| 2022-04-19 |
Class II
|
Terminated |
Z-1099-2022 |
LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5 |
— |
It was reported that a JOURNEY II BCS Femoral OXIN LT SZ5 was in a box labelled as a LEGION NARROW PS OXIN SZ 6N RT. |
| 2022-01-04 |
Class II
|
Ongoing |
Z-0548-2022 |
INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 ND |
— |
The affected screwdrivers are out of specification and may not mate with the Surfix Alpha Lock screw |
| 2021-12-14 |
Class II
|
Ongoing |
Z-0635-2022 |
Acufex Access Advanced Positioning Kit - indicated for use to position and distract the extremity of patient during open… |
— |
Products were shipped to the Global Distribution Center instead of the sterilizer and therefore product did not undergo the sterilization process |
| 2021-11-01 |
Class II
|
Ongoing |
Z-0366-2022 |
smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, R, 5H, 115MM, REF 72573202 |
— |
Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Erroneous data from the reports was … |
| 2021-11-01 |
Class II
|
Ongoing |
Z-0365-2022 |
smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, L, 5H, 115MM, REF 72573102 |
— |
Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Erroneous data from the reports was … |
| 2021-11-01 |
Class II
|
Ongoing |
Z-0364-2022 |
smith&nephew EVOS MEDIAL DISTAL FEMUR PLATE, R, 5H, 90MM, REF 72573201 |
— |
Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Erroneous data from the reports was … |
| 2021-11-01 |
Class II
|
Ongoing |
Z-0363-2022 |
smith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE, L, 5H, 90MM, REF 72573101 |
— |
Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Erroneous data from the reports was … |
| 2021-10-25 |
Class II
|
Ongoing |
Z-0265-2022 |
Smith and Nephew EVOS Self-Tapping Locking Screw SST: (1)REF 72413575, 3.5MM x 75MM, and (2) REF 72413570, 3.5MM X 70MM… |
— |
The labels on the packages of screws were switched. |
| 2021-09-20 |
Class II
|
Terminated |
Z-0143-2022 |
6.5MMX165MM CANNULATED SCREW |
— |
The product label incorrectly indicated that the screws are fully threaded, but the screws contained in the package were partially threaded. |
| 2021-05-19 |
Class II
|
Terminated |
Z-1951-2021 |
LEGION Posterior Stabilized OXINIUM Femoral Component, REF 71421216, Size 6, Left, Nonporous Femoral Component, A/P 65.5… |
— |
The device components experienced a manufacturing process error that resulted in surface damage from product handling. |
| 2021-04-08 |
Class II
|
Terminated |
Z-1510-2021 |
CANNU-Flex SILK Interference Screws 6 mmx 30 mm - Product Usage: used for interference fixation of bone-tendon-bone of s… |
— |
Mislabeled box contained a 6mm x 20mm screw instead of 6mm x 30mm screw |
| 2020-12-18 |
Class II
|
Terminated |
Z-0933-2021 |
VERSABOND AB 40 GRAMS FORMULATION 2, antibiotic infused bone cement, Product Number: 71271440 - Product Usage: VERSABOND… |
— |
Potential heat and humidity exposure. The affected lot contained an atypical sandy, flaky or grainy consistency when mixing. |
| 2020-11-02 |
Class II
|
Terminated |
Z-0772-2021 |
Bone fixation nail. TRIGEN INTERTAN - Product Usage: indicated for fractures of the femur including simple shaft fractur… |
— |
Manufacturing packaging error. |
| 2020-09-21 |
Class II
|
Terminated |
Z-0301-2021 |
5.5MM Arthrogarde Hip Access Cannula |
— |
The J Lock feature on the cannula body was manufactured incorrectly, preventing the cannula from locking into an irrigation extender or arthroscope in the corre… |
| 2020-09-21 |
Class II
|
Terminated |
Z-0118-2021 |
Genesis (GII) - Product Usage: designed for use in patients in primary and revision surgery, where the posterior cruciat… |
— |
The anterior locking detail does not meet its design specifications. |
| 2020-09-09 |
Class II
|
Ongoing |
Z-0175-2021 |
MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product Number: 72204984 |
— |
Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch |
| 2020-09-09 |
Class II
|
Ongoing |
Z-0174-2021 |
MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product Number: 72204983 |
— |
Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch |
| 2020-09-09 |
Class II
|
Ongoing |
Z-0173-2021 |
HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BL- Absorbable Suture anchor Product Number: 72203801 |
— |
Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch |
| 2020-09-09 |
Class II
|
Ongoing |
Z-0172-2021 |
HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BLK- Absorbable Suture anchor Product Number: 72203708 |
— |
Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch |
| 2020-09-09 |
Class II
|
Ongoing |
Z-0171-2021 |
HEALICOIL RG SA 5.5MM W/3 UB-BL CB BL BK- Absorbable Suture anchor Product Number: 72203707 |
— |
Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch |
| 2020-09-09 |
Class II
|
Ongoing |
Z-0170-2021 |
HEALICOIL RG SA 5.5MM W/2 UB-BL CBR BL-- Absorbable Suture anchor Product Number: 72203706 |
— |
Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch |
| 2020-09-09 |
Class II
|
Ongoing |
Z-0169-2021 |
HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BK-- Absorbable Suture anchor Product Number: 72203705 |
— |
Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch |
| 2020-09-09 |
Class II
|
Ongoing |
Z-0168-2021 |
HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL-- Absorbable Suture anchor Product Number: 72203704 |
— |
Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch |
| 2020-09-09 |
Class II
|
Ongoing |
Z-0167-2021 |
HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL- Absorbable Suture anchor Product Number: 72203697 |
— |
Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch |
| 2020-09-09 |
Class II
|
Ongoing |
Z-0166-2021 |
OSTEORAPTOR CRVD 2.3 SA UB COBRD BLACK- Absorbable Suture anchor Product Number: 72203291 |
— |
Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch |
| 2020-09-09 |
Class II
|
Ongoing |
Z-0165-2021 |
OSTEORAPTOR CRVD 2.3 SA UB COBRD BLUE- Absorbable Suture anchor Product Number: 72203290 |
— |
Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch |
| 2020-09-09 |
Class II
|
Ongoing |
Z-0164-2021 |
TWINFIX ULTRA HA 6.5 W/2 UB (BLUE & BLK)- Absorbable Suture anchor Product Number: 72202631 |
— |
Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch |
| 2020-09-09 |
Class II
|
Ongoing |
Z-0163-2021 |
TWINFIX ULTRA HA 5.5 W/2 UB BLUE & BLK- Absorbable Suture anchor Product Number: 72202626 |
— |
Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch |
| 2020-09-09 |
Class II
|
Ongoing |
Z-0162-2021 |
TWINFIX ULTRA HA 4.5 W/2 UB BLUE & BLK- Absorbable Suture anchor Product Number: 72202624 |
— |
Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch |
| 2020-09-09 |
Class II
|
Ongoing |
Z-0161-2021 |
TWINFIX ULTRA PLLA HA 6.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202620 |
— |
Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch |
| 2020-09-09 |
Class II
|
Ongoing |
Z-0160-2021 |
TWINFIX ULTRA PLLA HA 5.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202616 |
— |
Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch |
| 2020-09-09 |
Class II
|
Ongoing |
Z-0159-2021 |
TWINFIX ULTRA PLLA HA 4.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202612 |
— |
Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch |
| 2020-09-09 |
Class II
|
Ongoing |
Z-0158-2021 |
TWINFIX ULTRA PLLA/HA 6.5 W/3 UB- Absorbable Suture anchor Product Number: 72202610 |
— |
Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch |
| 2020-09-09 |
Class II
|
Ongoing |
Z-0157-2021 |
TWINFIX ULTRA 6.5MM PLLA/HA 2 UBWHT/BL-Absorbable Suture anchor Product Number: 72202608 |
— |
Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch |
| 2020-09-09 |
Class II
|
Ongoing |
Z-0156-2021 |
TWINFIX ULTRA PLLA/HA 5.5 W/3 UB-Absorbable Suture anchor Product Number: 72202603 |
— |
Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch |
| 2020-09-09 |
Class II
|
Ongoing |
Z-0155-2021 |
TWINFIX ULTRA 5.5MM PLLA/HA 2 UBWHT/BL--Absorbable Suture anchor Product Number: 72202602 |
— |
Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch |
| 2020-09-09 |
Class II
|
Ongoing |
Z-0154-2021 |
OSTEORAPTOR 2.9 W 1UB II BLUE--Absorbable Suture anchor Product Number: 72202165 |
— |
Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch |
| 2020-09-09 |
Class II
|
Ongoing |
Z-0153-2021 |
OSTEORAPTOR 2.9 W. 2 UB WHITE / BLACK -Absorbable Suture anchor Product Number: 72201996 |
— |
Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch |
| 2020-09-09 |
Class II
|
Ongoing |
Z-0152-2021 |
OSTEORAPTOR 2.9 W/ 2 UB WHITE / BLUE -Absorbable Suture anchor Product Number: 72201995 |
— |
Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch |
| 2020-09-09 |
Class II
|
Ongoing |
Z-0151-2021 |
OSTEORAPTOR 2.9 W/ 1 UB COBRAID BLUE -Absorbable Suture anchor Product Number: 72201994 |
— |
Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch |
| 2020-09-09 |
Class II
|
Ongoing |
Z-0150-2021 |
OSTEORAPTOR 2.3 W. UB COBRAID BLUE-Absorbable Suture anchor Product Number: 72201993 |
— |
Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch |
| 2020-09-09 |
Class II
|
Ongoing |
Z-0149-2021 |
OSTEORAPTOR 2.3 W/ 1 UB COBRAID BLACK-Absorbable Suture anchor Product Number: 72201992 |
— |
Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch |
| 2020-09-09 |
Class II
|
Ongoing |
Z-0148-2021 |
OSTEORAPTOR 2.3 W 1UB II BLUE-Absorbable Suture anchor Product Number: 72201991 |
— |
Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch |
| 2020-09-09 |
Class II
|
Ongoing |
Z-0147-2021 |
RAPTORMITE 3.7MM AB W/ NEEDLES AND TWO-Absorbable Suture anchor Product Number: 72201805 |
— |
Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch |
| 2020-09-09 |
Class II
|
Ongoing |
Z-0146-2021 |
BIORAPTOR 2.9MM SUTURE ANCHOR-Absorbable Suture anchor Product Number: 72201702 |
— |
Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch |
| 2020-09-09 |
Class II
|
Ongoing |
Z-0145-2021 |
ULTRA FAST-FIX AB ASSEMBLY-REVERSE CURVE-Absorbable Suture anchor Product Number: 72201495 |
— |
Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch |
| 2020-09-09 |
Class II
|
Ongoing |
Z-0144-2021 |
ULTRA FAST-FIX AB ASSEMBLY - CURVED-Absorbable Suture anchors Product Number: 72201494 |
— |
Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch |
| 2020-09-09 |
Class II
|
Ongoing |
Z-0143-2021 |
ULTRA FAST-FIX AB ASSEMBLY - STRAIGHT-Absorbable Suture anchors Product Number: 72201493 |
— |
Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch |
| 2020-09-09 |
Class II
|
Ongoing |
Z-0142-2021 |
TWINFIX AB 5.0 SUTR ANCHR W/2 38 DURAB-Absorbable Suture anchors Product Number: 72200785 |
— |
Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch |
| 2020-09-09 |
Class II
|
Ongoing |
Z-0141-2021 |
TWINFIX AB 5.0 SUTR ANCHR W/2 38 ULTRA-Absorbable Suture anchors Product Number:72200777 |
— |
Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch |
| 2020-09-09 |
Class II
|
Ongoing |
Z-0140-2021 |
TWINFIX 6.5MM AB PRELOADED SUTURE ANCHOR- Absorbable Suture anchors Product Number: 7210713 |
— |
Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch |
| 2020-09-09 |
Class II
|
Ongoing |
Z-0139-2021 |
TWINFIX 6.5MM AB PRELOADED ULTRABRAID- Absorbable Suture anchors Product Number: 7210712 |
— |
Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch |
| 2020-09-09 |
Class II
|
Ongoing |
Z-0138-2021 |
TWINFIX 5.0MM AB SUTURE ANCHOR-Absorbable Suture anchors Product Number: 7210711 |
— |
Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch |
| 2020-09-09 |
Class II
|
Ongoing |
Z-0137-2021 |
TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO- Absorbable Suture anchors Product Number: 7210710 |
— |
Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch |
| 2020-09-09 |
Class II
|
Ongoing |
Z-0136-2021 |
TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO Absorbable Suture anchors Product Number: 7210309 |
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Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch |
| 2020-08-24 |
Class II
|
Terminated |
Z-2945-2020 |
EVOS Screws - Product Usage: is a part of the EVOS MINI plating system, indicated for fracture fixation, arthrodesis, re… |
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Multiple or incorrect expiration dates were provided on the affected designation labels. |
| 2020-08-03 |
Class II
|
Ongoing |
Z-2818-2020 |
Single RIKKI Retractor, Catalog #71934609 - Product Usage: is used during surgery to hold soft tissue away from the surg… |
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The products were improperly heat treated. |
| 2020-07-16 |
Class II
|
Ongoing |
Z-2774-2020 |
Tibial knee prosthesis |
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Due to an inconsistency in the raw material process, specific lots may contain units with internal non-homogenous material defects. |
| 2020-06-29 |
Class II
|
Terminated |
Z-2777-2020 |
PERI-LOC TARGETER 4.5MM DISTAL FEMUR, HANDLE, LEFT, NON-STERILE - Product Usage: used for adult and pediatric patients, … |
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The 4.5MM PeriLoc Targeter right hand part was anodized green and was marked as a left-hand part. |
| 2020-06-24 |
Class II
|
Ongoing |
Z-2746-2020 |
SUTUREFIX ULTRA Suture, Product number 72203855 |
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A packaging error resulted in a XL drill being presented for use instead of the S drill. The XL drill is one inch longer than the S drill. |
| 2020-06-24 |
Class II
|
Ongoing |
Z-2702-2020 |
Smith & Nephew T-F1X0 RCG Drill Pac, 2 mm Drill & (2) Sleeves - Product Usage: indicated for use in surgical arthroscopi… |
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The T-Fix sterile package contains only one sleeve instead of two, The device will not perform as intended for the second bone tunnel due to the absence of the… |
| 2020-06-24 |
Class II
|
Terminated |
Z-2685-2020 |
TRIGEN, Intramedullary nail - Product Usage: is intended to provide resistance for screw back-out. It provides additiona… |
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A manufacturing error which resulted in the re-sterilization of the ultra-high-molecular-weight polyethylene (UHMWPE) sleeve. |
| 2020-04-22 |
Class II
|
Ongoing |
Z-2336-2020 |
smith&nephew R3 MULTI HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF… |
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A manufacturing error resulted in out of specification R3 Acetabular Shells |
| 2020-04-22 |
Class II
|
Ongoing |
Z-2335-2020 |
smith&nephew R3 MULTI HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Sizes REF/product … |
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A manufacturing error resulted in out of specification R3 Acetabular Shells |
| 2020-04-22 |
Class II
|
Ongoing |
Z-2334-2020 |
smith&nephew R3 THREE HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF… |
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A manufacturing error resulted in out of specification R3 Acetabular Shells |
| 2020-04-22 |
Class II
|
Ongoing |
Z-2333-2020 |
smith&nephew R3 THREE HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product n… |
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A manufacturing error resulted in out of specification R3 Acetabular Shells |
| 2020-04-22 |
Class II
|
Ongoing |
Z-2332-2020 |
smith&nephew R3 ZERO HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/… |
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A manufacturing error resulted in out of specification R3 Acetabular Shells |
| 2020-04-22 |
Class II
|
Ongoing |
Z-2331-2020 |
smith&nephew R3 NO HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product numb… |
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A manufacturing error resulted in out of specification R3 Acetabular Shells |
| 2020-03-17 |
Class II
|
Ongoing |
Z-1757-2020 |
Smith & Nephew FOOTPRINT Ultra PK Suture Anchor, 5.5mm Part Number: 72202902 |
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Space between the device and the packaging permits excessive movement which could potentially lead to the displacement of the anchor s tip protector allowing th… |
| 2020-03-17 |
Class II
|
Ongoing |
Z-1756-2020 |
Smith & Nephew FOOTPRINT ULTRA PK SUTURE ANCHOR 4.5 Part Number: 72202901 |
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Space between the device and the packaging permits excessive movement which could potentially lead to the displacement of the anchors tip protector allowing the… |
| 2020-02-27 |
Class II
|
Terminated |
Z-1634-2020 |
NAVIO Soft Tissue Protector, included in instrument kits. The NAVIO Tissue Protector is a reusable instrument design… |
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Potential for the NAVIO Soft Tissue Protector to become stuck or bound to the bone pin intraoperatively when inserting the NAVIO bone pins. |
| 2020-01-28 |
Class II
|
Terminated |
Z-2133-2020 |
JOURNEY II UNI RESECTION PREP TRIAL, RIGHT MEDIAL/ LEFT LATERAL - Product Usage: The JOURNEY II Uni Resection Prep Trial… |
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The spike rail was manufactured with an oversized thru-hole which could potentially cause the dowel pin to fall out and the device to disassemble. |
| 2020-01-28 |
Class II
|
Terminated |
Z-2132-2020 |
JOURNEY II UNI RESECTION PREP TRIAL, LEFT MEDIAL/ RIGHT LATERAL - Product Usage: The JOURNEY II Uni Resection Prep Trial… |
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The spike rail was manufactured with an oversized thru-hole which could potentially cause the dowel pin to fall out and the device to disassemble. |