| 2026-02-25 |
Class II
|
Ongoing |
Z-1703-2026 |
2.4 VOLT(TM) TAP CORTEX SCREW TO 90MM. Part Number: 03.424.126-US. |
— |
A full lot swap between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.424.126 lot 68982P8, resulting in the bones taps having an incor… |
| 2026-02-25 |
Class II
|
Ongoing |
Z-1702-2026 |
2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US. |
— |
A full lot swap between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.424.126 lot 68982P8, resulting in the bones taps having an incor… |
| 2025-09-26 |
Class II
|
Ongoing |
Z-0229-2026 |
LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 42MM / XL25/ STER. Product Code: 04.045.342TS. Used in RFN-ADVANCEDTM Ret… |
— |
Although the etched length on the screw is correct, the length marked on the external packaging is incorrect. Specifically, 42mm screws were packaged and labele… |
| 2025-09-26 |
Class II
|
Ongoing |
Z-0228-2026 |
LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM / XL25/ STER. Product Code: 04.045.346TS. Used in RFN-ADVANCEDTM Ret… |
— |
Although the etched length on the screw is correct, the length marked on the external packaging is incorrect. Specifically, 42mm screws were packaged and labele… |
| 2024-04-25 |
Class II
|
Ongoing |
Z-1916-2024 |
STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC-Intended for tightening, loosening, or removing of screw implants dur… |
— |
Stardrive Screwdrivers manufactured without a 5-degree relief cut around the tip and will not engage with their respective 1.3mm and 1.5mm screws, may result in… |
| 2024-01-24 |
Class II
|
Ongoing |
Z-1242-2024 |
Opal, Intervertebral Cage, 10x32mm, h 11mm, Revolvable-Indicated for degenerative spine disease Part Number: 08.803.231… |
— |
Products not sterilized, sterility cannot be confirmed |
| 2024-01-24 |
Class II
|
Ongoing |
Z-1241-2024 |
VA-LCP Clavicle Plate 2.7, shaft, CS1, right-Intended for fixation of clavicle bone fragments. Part Number: 02.112.621S |
— |
Products not sterilized, sterility cannot be confirmed |
| 2024-01-24 |
Class II
|
Ongoing |
Z-1240-2024 |
TFNA Femoral Nail 11mm, right, 130¿, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractu… |
— |
Products not sterilized, sterility cannot be confirmed |
| 2024-01-24 |
Class II
|
Ongoing |
Z-1239-2024 |
TFNA Femoral Nail 9mm, right, 130¿, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractur… |
— |
Products not sterilized, sterility cannot be confirmed |
| 2024-01-24 |
Class II
|
Ongoing |
Z-1238-2024 |
RAPIDSORB IPS Battery Pack, Sterile-Intended for use in non-load bearing fracture repair and reconstructive procedures o… |
— |
Products not sterilized, sterility cannot be confirmed |
| 2024-01-24 |
Class II
|
Ongoing |
Z-1237-2024 |
RIA Tube Assembly, minimum 520 mm length, sterile- intended for use in adults and adolescents (12-21 years) to clear th… |
— |
Products not sterilized, sterility cannot be confirmed |
| 2024-01-24 |
Class II
|
Ongoing |
Z-1236-2024 |
2.5MM DRILL BIT/QC/GOLD/110MM STERILE-surgical, orthopedic, pneumatic powered & accessory/attachment Product Code: 310.… |
— |
Products not sterilized, sterility cannot be confirmed |
| 2024-01-24 |
Class II
|
Ongoing |
Z-1235-2024 |
1.5MM Drill Bit/QC/85MM Sterile-surgical, orthopedic, pneumatic powered & accessory/attachment Part Number: 310.15S |
— |
Products not sterilized, sterility cannot be confirmed |
| 2024-01-24 |
Class II
|
Ongoing |
Z-1234-2024 |
13 mm Titanium Hindfoot Arthrodesis Cannulated Nails EX, sterile -Intended to facilitate tibiotalocalcaneal arthrodesis … |
— |
Products not sterilized, sterility cannot be confirmed |
| 2023-02-01 |
Class II
|
Ongoing |
Z-1248-2023 |
TFN-Advanced Femoral Nail 12MM/130 DEG TI CANN TFNA 170MM STERILE. Intended for temporary fixation and stabilization … |
— |
TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, and TFNA Femoral Nails labeled and etched as 170mm may measure 200mm in length |
| 2023-02-01 |
Class II
|
Ongoing |
Z-1247-2023 |
TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 170MM - STERILE. Intended for temporary fixation and stabilization … |
— |
TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, and TFNA Femoral Nails labeled and etched as 170mm may measure 200mm in length |
| 2023-02-01 |
Class II
|
Ongoing |
Z-1246-2023 |
TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 200MM STERILE. Intended for temporary fixation and stabilization … |
— |
TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, and TFNA Femoral Nails labeled and etched as 170mm may measure 200mm in length |
| 2022-09-27 |
Class II
|
Ongoing |
Z-0101-2023 |
DePuy Synthes Hammertoe Continuous Compression Implants, Product No. 46.239.001 |
— |
The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant … |
| 2022-09-27 |
Class II
|
Ongoing |
Z-0100-2023 |
SPEED 9X10X10mm Continuous Compression Implant, Product No. SE-0910 |
— |
The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant … |
| 2022-09-27 |
Class II
|
Ongoing |
Z-0099-2023 |
SPEED 15X12X12mm Continuous Compression Implant, Product No. SE-1512 |
— |
The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant … |
| 2022-09-27 |
Class II
|
Ongoing |
Z-0098-2023 |
SPEEDSHIFT20x20x20 Offset 10mm Implant Drill Kit, Product No. SE-2020-10. Used with DePuy Synthes SPEEDSHIFT Continuous… |
— |
The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant … |
| 2022-08-30 |
Class II
|
Ongoing |
Z-0008-2023 |
Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001 |
— |
Drill Pin (drill bit) is not compatible with the Drill Template included in the kit due to a packaging error, result in a surgical delay and may cause soft tis… |
| 2022-04-07 |
Class II
|
Ongoing |
Z-1072-2022 |
Radial Head Replacement System Implant is a one-piece, stemmed radial head replacement. The radial head is available in … |
— |
DePuy Synthes Radial Head Replacement System Contraindications added to Electronic Instructions for Use (e-IFU): Absolute contraindications include: Infection, … |
| 2021-12-22 |
Class II
|
Ongoing |
Z-0634-2022 |
Universal Chuck-The Universal Chuck is an Instrument Handle provided as an alternative instrument available for use in t… |
— |
Top cap may loosen and detach if the Universal Chuck becomes jammed and the user attempts to manually free the device, internal ball bearings may fall out onto … |
| 2020-11-19 |
Class II
|
Terminated |
Z-0587-2021 |
DePuy Synthes 18.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.032S |
— |
RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommend… |
| 2020-11-19 |
Class II
|
Terminated |
Z-0586-2021 |
DePuy Synthes 17.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.031S |
— |
RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommend… |
| 2020-11-19 |
Class II
|
Terminated |
Z-0585-2021 |
DePuy Synthes 17.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.030S |
— |
RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommend… |
| 2020-11-19 |
Class II
|
Terminated |
Z-0584-2021 |
DePuy Synthes 16.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.029S |
— |
RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommend… |
| 2020-11-19 |
Class II
|
Terminated |
Z-0583-2021 |
DePuy Synthes 16.0MM REAMER HEAD FOR RIA 2 STERILE--Orthopedic manual surgical instrument Part Code: 03.404.028S |
— |
RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommend… |
| 2020-11-19 |
Class II
|
Terminated |
Z-0582-2021 |
DePuy Synthes 15.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.027S |
— |
RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommend… |
| 2020-11-19 |
Class II
|
Terminated |
Z-0581-2021 |
DePuy Synthes 15.0MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code: 03.404.026S |
— |
RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommend… |
| 2020-11-19 |
Class II
|
Terminated |
Z-0580-2021 |
DePuy Synthes 14.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.025S |
— |
RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommend… |
| 2020-11-19 |
Class II
|
Terminated |
Z-0579-2021 |
DePuy Synthes 14.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.024S |
— |
RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommend… |
| 2020-11-19 |
Class II
|
Terminated |
Z-0578-2021 |
DePuy Synthes 13.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.023S |
— |
RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommend… |
| 2020-11-19 |
Class II
|
Terminated |
Z-0577-2021 |
DePuy Synthes 13.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.022S |
— |
RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommend… |
| 2020-11-19 |
Class II
|
Terminated |
Z-0576-2021 |
DePuy Synthes 12.5MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code: 03.404.021S |
— |
RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommend… |
| 2020-11-19 |
Class II
|
Terminated |
Z-0575-2021 |
DePuy Synthes 12.0MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code: 03.404.020S |
— |
RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommend… |
| 2020-11-19 |
Class II
|
Terminated |
Z-0574-2021 |
DePuy Synthes 11.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.019S |
— |
RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommend… |
| 2020-11-19 |
Class II
|
Terminated |
Z-0573-2021 |
DePuy Synthes 11.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.018S |
— |
RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommend… |
| 2020-11-19 |
Class II
|
Terminated |
Z-0572-2021 |
DePuy Synthes 10.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.017S |
— |
RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommend… |
| 2020-11-19 |
Class II
|
Terminated |
Z-0571-2021 |
DePuy Synthes 10.0MM REAMER HEAD FOR RIA 2, STERILE-Orthopedic manual surgical instrument Part Code: 03.404.016S |
— |
RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommend… |
| 2020-09-21 |
Class III
|
Terminated |
Z-0417-2021 |
3.0MM LOCKING SCREW LOW PROFILE (TI) Product Number: 495-491 - Product Usage: is a vertebral body replacement device f… |
— |
Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device" |
| 2020-09-21 |
Class III
|
Terminated |
Z-0416-2021 |
STANDARD RING 22MM X 28MM (TI) Product Number: 495-406 - Product Usage: is a vertebral body replacement device for the … |
— |
Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device" |
| 2020-09-21 |
Class III
|
Terminated |
Z-0415-2021 |
STANDARD RING 17MM X 22MM (TI) Product Number: 495-405 - Product Usage: is a vertebral body replacement device for the c… |
— |
Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device" |
| 2020-09-21 |
Class III
|
Terminated |
Z-0414-2021 |
END RING 22MM X 28MM LATERAL OR ANTERIOR/5 DEG (TI) Product Number: 495-398 - Product Usage: is a vertebral body repla… |
— |
Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device" |
| 2020-09-21 |
Class III
|
Terminated |
Z-0413-2021 |
END RING 22MM X 28MM LATERAL OR ANTERIOR/0 DEG (TI) Product Number: 495-396 - Product Usage: is a vertebral body repla… |
— |
Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device" |
| 2020-09-21 |
Class III
|
Terminated |
Z-0412-2021 |
END RING 17MM X 22MM LATERAL OR ANTERIOR/5 DEG (TI) Product Number: 495.394 - Product Usage: is a vertebral body repla… |
— |
Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device" |
| 2020-09-21 |
Class III
|
Terminated |
Z-0411-2021 |
END RING 17MM X 22MM LATERAL OR ANTERIOR/0 DEG (TI) Product Number: 495.392 - Product Usage: is a vertebral body repla… |
— |
Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device" |
| 2020-09-21 |
Class III
|
Terminated |
Z-0410-2021 |
END RING 15MM DIA/0 DEG (TI) Product Number: 495.386 - Product Usage: is a vertebral body replacement device for the ce… |
— |
Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device" |
| 2020-09-21 |
Class III
|
Terminated |
Z-0409-2021 |
END RING 12MM DIA/0 DEG (TI) Product Number: 495.385 - Product Usage: is a vertebral body replacement device for the ce… |
— |
Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device" |
| 2020-09-21 |
Class III
|
Terminated |
Z-0408-2021 |
END RING 10MM DIA/0 DEG (TI) Product Number: 495.384 - Product Usage: is a vertebral body replacement device for the ce… |
— |
Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device" |
| 2020-09-21 |
Class III
|
Terminated |
Z-0407-2021 |
SYNMESH¿ 22MM X 28MM 88MM HEIGHT (TI) Product Number: 495.379 - Product Usage: is a vertebral body replacement device … |
— |
Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device" |
| 2020-09-21 |
Class III
|
Terminated |
Z-0406-2021 |
SYNMESH 17MM X 22MM 88MM HEIGHT (TI) Product Number: 495-374 - Product Usage: is a vertebral body replacement device f… |
— |
Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device" |
| 2020-09-21 |
Class III
|
Terminated |
Z-0405-2021 |
SYNMESH 15MM DIA 88MM HEIGHT (TI) Product Number: 495.366 - Product Usage: is a vertebral body replacement device for … |
— |
Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device" |
| 2020-09-21 |
Class III
|
Terminated |
Z-0404-2021 |
SYNMESH 12MM DIA 88MM HEIGHT (TI) Product Number: 495.357 - Product Usage: is a vertebral body replacement device for … |
— |
Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device" |
| 2020-09-21 |
Class III
|
Terminated |
Z-0403-2021 |
DePuy Synthes SYNMESH 10MM DIA 18MM HEIGHT (TI) Product Number: 495.344 - Product Usage: is a vertebral body replacemen… |
— |
Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device" |
| 2020-07-21 |
Class II
|
Terminated |
Z-2816-2020 |
DePuy Synthes Trauma LCP One-Third Tubular Plate with Collar 8 Holes / 93mm - Product Usage: intended for fixation of fr… |
— |
May have one or more dimensional features out of tolerance includes: thread pitch diameter depth, thread minor diameter depth, plate thickness and end length ou… |