| 2023-07-20 |
Class II
|
Ongoing |
Z-2518-2023 |
For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R |
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Trocar manufactured with the shaft too long and does not meet manufacturing specifications. As a result, when used with the 30¿ neuroendoscope, a portion of the… |
| 2023-05-18 |
Class II
|
Ongoing |
Z-2146-2023 |
Aesculap Surgical Needle, straight, 3 1/2", (90 mm), 13GA, width: 2,400 mm, non-sterile, reusable Article Number: MD610 |
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Incorrect product code marked on the product, etched with product code MD611, however; the correct product code is MD610. |
| 2023-03-21 |
Class II
|
Ongoing |
Z-1569-2023 |
Aesculap Caiman Articulating D5/360MM - An electrosurgical cutting and coagulation device for cutting/coagulation/ablat… |
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Potential for the spring to become loose and fall out of the device, if the spring falls out during a surgical procedure, it may enter the patient's body. |
| 2023-02-23 |
Class II
|
Ongoing |
Z-1430-2023 |
Caspar Cervical Retractor (CCR) Basket ME754 - Lid Only and ME764 Casper Cervical Retractor (CCR) Basket Full System - … |
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Mislabeled: Product is marked with GTIN # 04046955299592 however; the correct GTIN # is 04046955299607. |
| 2022-07-15 |
Class II
|
Ongoing |
Z-1638-2022 |
Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilization of the l… |
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Potential for the incorrect screw to be included in the package. |
| 2022-07-14 |
Class II
|
Terminated |
Z-1516-2022 |
Aeos¿ Robotic Digital Microscope with software versions 2.7 or earlier Article Number: PV010 |
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Application error problems: Rebalance scope message: 1.Rebalancing process 2.Usage of Robot Recovery: 3. Autofocus not available: |
| 2021-10-25 |
Class II
|
Terminated |
Z-1410-2022 |
MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium Instrument Set, ST-0441 |
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Set screwdriver fails during surgery by deforming at the tip during engagement and manipulation of the implant. |
| 2021-06-30 |
Class II
|
Terminated |
Z-1406-2022 |
LEFT CORONAL BENDER, TEK1939. Instrument used during spinal surgery. |
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Customized coronal rod benders may deform the implant when used with the spinal system devices. |
| 2021-06-30 |
Class II
|
Terminated |
Z-1405-2022 |
RIGHT CORONAL BENDER, TEK1940. Instrument used during spinal surgery. |
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Customized coronal rod benders may deform the implant when used with the spinal system devices. |
| 2021-04-16 |
Class II
|
Terminated |
Z-2579-2021 |
PAS-PORT PROXIMAL ANASTOMOSIS DEVICE US Catalog Number: FG-000001-13 |
— |
Malfuncton-Implant did not deploy successfully may necessitate the need for an additional medical intervention for patients which would result in a potential d… |
| 2021-04-16 |
Class II
|
Terminated |
Z-2578-2021 |
PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM Catalog Number: FC700SU |
— |
Malfuncton-Implant did not deploy successfully may necessitate the need for an additional medical intervention for patients which would result in a potential d… |
| 2021-03-19 |
Class II
|
Terminated |
Z-2516-2021 |
Univation X System Tray Sysem knee implant devices as follows: Tray Number/Set Name/Set Number NM1090R Navigation Set… |
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Malfunction- loosening of the implant resulting in a potential revision surgery |
| 2021-03-19 |
Class II
|
Terminated |
Z-2515-2021 |
Univation X System knee implant devices as follows: Catalog/Product: NO180Z AS UNIVATION XF FEMUR CEMENTED F1 RM; N… |
— |
Malfunction- loosening of the implant resulting in a potential revision surgery |
| 2021-03-19 |
Class II
|
Terminated |
Z-2514-2021 |
Univation X System knee implant devices as follows: Catalog/Product: NO156Z AS UNIVATION XF TIBIA CEMENTED T1 RM; N… |
— |
Malfunction- loosening of the implant resulting in a potential revision surgery |
| 2021-03-19 |
Class II
|
Terminated |
Z-2513-2021 |
Univation X System knee implant devices as follows: Catalog/Product: NL494 UNIVATION F MENISCAL COMP.T1 RM/LM 11MM; … |
— |
Malfunction- loosening of the implant resulting in a potential revision surgery |
| 2021-03-19 |
Class II
|
Terminated |
Z-2512-2021 |
Univation X System knee implant devices as follows: Catalog/Product: NL488 UNIVATION F MENISCAL COMP.T1 RM/LM 10MM; … |
— |
Malfunction- loosening of the implant resulting in a potential revision surgery |
| 2021-03-19 |
Class II
|
Terminated |
Z-2511-2021 |
Univation X System knee implant devices as follows: Catalog/Product: NL482 UNIVATION F MENISCAL COMP.T1 RM/LM 9MM; N… |
— |
Malfunction- loosening of the implant resulting in a potential revision surgery |
| 2021-03-19 |
Class II
|
Terminated |
Z-2510-2021 |
Univation X System knee implant devices as follows: Catalog/Product: NL476 UNIVATION F MENISCAL COMP.T1 RM/LM 8MM; N… |
— |
Malfunction- loosening of the implant resulting in a potential revision surgery |
| 2021-03-19 |
Class II
|
Terminated |
Z-2509-2021 |
Univation X System knee implant devices as follows: Catalog/Product: NL470 UNIVATION F MENISCAL COMP.T1 RM/LM 7MM; N… |
— |
Malfunction- loosening of the implant resulting in a potential revision surgery |
| 2021-02-19 |
Class II
|
Completed |
Z-1409-2022 |
Universal Robot UR5 arm, PV010204 subcomponent of Aesculap Aeos Digital Microscope System, PV010 |
— |
Malfunction of the robotic arm preventing further movement of the robotic arm and requiring restart of the robotic digital microscope system. |
| 2020-11-18 |
Class II
|
Terminated |
Z-1429-2022 |
ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R |
— |
Fracture or breakage of the spinal fixation arm at the downtube instrument if the 90 degree angle is not met when using the removal key with the spinal fixation… |
| 2020-09-08 |
Class II
|
Terminated |
Z-1448-2022 |
AESCULAP S4 Cervical Cross Connector L 42-58mm, S4C CROSS CONNECTOR VARIABLE 42-58MM, product code SW117T. Used in spin… |
— |
Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle … |
| 2020-09-08 |
Class II
|
Terminated |
Z-1447-2022 |
AESCULAP S4 Cervical Cross Connector L 33-42mm, S4C CROSS CONNECTOR VARIABLE 33-42MM, product code SW116T. Used in spin… |
— |
Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle … |
| 2020-09-08 |
Class II
|
Terminated |
Z-1446-2022 |
AESCULAP S4 Cervical Cross Connector L 28-33mm, S4C CROSS CONNECTOR VARIABLE 28-33MM, SW115T. Used in spinal fusion sur… |
— |
Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle … |
| 2020-09-08 |
Class II
|
Terminated |
Z-1445-2022 |
AESCULAP S4 Cervical Cross Connector, L26mm, S4C CROSS CONNECTOR FIXED 26MM, product code SW114T. Used in spinal fusion… |
— |
Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle … |
| 2020-09-08 |
Class II
|
Terminated |
Z-1444-2022 |
AESCULAP S4 Cervical Cross Connector L24mm, S4C CROSS CONNECTOR FIXED 24MM, product code SWT113T. Used in spinal fusio… |
— |
Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle … |
| 2020-09-08 |
Class II
|
Terminated |
Z-1443-2022 |
AESCULAP S4 Cervical Cross Connector L22mm, S4C CROSS CONNECTOR FIXED 22MM, product code SW112T. Used in spinal fusion … |
— |
Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle … |
| 2020-07-13 |
Class II
|
Terminated |
Z-1428-2022 |
ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R |
— |
Fracture or breakage of the spinal fixation arm at the downtube instrument if the 90 degree angle is not met when using the removal key with the spinal fixation… |
| 2020-04-01 |
Class II
|
Completed |
Z-1482-2022 |
PRESTIGE RETRACTION GRASPER, W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8361-10 |
— |
Endoscopic graspers may become separated at the weld from handle to the shaft of the device. |
| 2020-04-01 |
Class II
|
Completed |
Z-1481-2022 |
PRESTIGE ATRAUMATIC GRASPER W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8360-10 |
— |
Endoscopic graspers may become separated at the weld from handle to the shaft of the device. |
| 2020-01-21 |
Class II
|
Terminated |
Z-1482-2020 |
COLUMBUS REV F TIBIA OFFSET CEMENTED, Knee implant components, various sizes, model nos. NR068K NR068Z NR070K NR070Z… |
— |
Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging. |
| 2020-01-21 |
Class II
|
Terminated |
Z-1481-2020 |
AS COLUMBUS CR/PS TIB.PLAT.CEMENTED,Knee implant components, various sizes, model nos. NN058Z NN070Z NN071Z NN072Z … |
— |
Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging. |
| 2020-01-21 |
Class II
|
Terminated |
Z-1480-2020 |
COLUMBUS CRA/PSA TIB.PLAT.CEMENTED, Knee implant components, various sizes, model nos. NN469K NN470K NN471K NN472K … |
— |
Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging. |
| 2020-01-21 |
Class II
|
Terminated |
Z-1479-2020 |
COLUMBUS CR/PS TIB.PLAT.PLASMAPORE, Knee implant components, various sizes, model nos. NN081K NN082K NN083K NN084K … |
— |
Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging. |
| 2020-01-21 |
Class II
|
Terminated |
Z-1478-2020 |
Columbus R/PS TIB.PLATEAU Cemented, various sizes, Knee implant components, model nos. NN058K NN070K NN071K NN072K N… |
— |
Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging. |