Stryker End Cap T2 Humerus ¿6mm, 15mm height Catalog Number: 18300015S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of ...
Reason: Seal integrity of the blister pack may be compromised and sterility cannot be assured
Z-2378-2020June 24, 2020Selzach
Stryker GmbH
Class IITerminated
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x40 mm Catalog Number: 18965040S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabiliz...
Reason: Seal integrity of the blister pack may be compromised and sterility cannot be assured
Z-2384-2020June 24, 2020Selzach
Stryker GmbH
Class IITerminated
Stryker End Cap, Standard T2 Humerus ¿6 mm Catalog Number: 18300003S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bo...
Reason: Seal integrity of the blister pack may be compromised and sterility cannot be assured
Z-2376-2020June 24, 2020Selzach
Stryker GmbH
Class IITerminated
Stryker End Cap T2 Tibia +10 mm Catalog Number: 18220010S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
Reason: Seal integrity of the blister pack may be compromised and sterility cannot be assured
Z-2375-2020June 24, 2020Selzach
Acuity Surgical Devices, LLC
Class IIOngoing
A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A Link Z Ti Unitary Open Interbody 32x24x12 7 A Link Z Ti Unitary Open Interbody 32x24x12 12 A Link Z Ti Unitary Open Interbody 32...
Reason: Due to a manufacturing process issue, it allowed vertebral body bone screws to not seat properly within the spinal device/cage.
Z-2355-2020June 17, 2020Irving, TX
Smith & Nephew, Inc.
Class IIOngoing
smith&nephew R3 THREE HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 40MM 71335540 42MM 71335542 44MM 71335544 46MM 71335546 48MM 71335548...
Reason: A manufacturing error resulted in out of specification R3 Acetabular Shells
Z-2333-2020June 17, 2020Memphis, TN
Smith & Nephew, Inc.
Class IIOngoing
smith&nephew R3 NO HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71331842 48MM 71331848 50MM 71331850 52MM 71331852 54MM 71331854 ...
Reason: A manufacturing error resulted in out of specification R3 Acetabular Shells
Z-2331-2020June 17, 2020Memphis, TN
Smith & Nephew, Inc.
Class IIOngoing
smith&nephew R3 THREE HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71331942 46MM 71331946 48MM 71331948 50MM 71331950 52M...
Reason: A manufacturing error resulted in out of specification R3 Acetabular Shells
Z-2334-2020June 17, 2020Memphis, TN
Acuity Surgical Devices, LLC
Class IIOngoing
A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A Link Z Ti Unitary Plate-Cage 32x21x15 7 A Link Z Ti Unitary Plate-Cage 32x21x15 12 A Link Z Ti Unitary Plate-Cage 32x21x15 16 A...
Reason: Due to a manufacturing process issue, it allowed vertebral body bone screws to not seat properly within the spinal device/cage.
Z-2354-2020June 17, 2020Irving, TX
Smith & Nephew, Inc.
Class IIOngoing
smith&nephew R3 ZERO HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71332242 46MM 71332246 48MM 71332248 50MM 71332250 52MM...
Reason: A manufacturing error resulted in out of specification R3 Acetabular Shells
Reason: A material weakness adjacent to the polymer fill channel may become compromised during pressurization with liquid polymer. Polymer leaks may occur during implantation of abdominal ...
Z-2263-2020June 17, 2020Santa Rosa, CA
Smith & Nephew, Inc.
Class IIOngoing
smith&nephew R3 MULTI HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Sizes REF/product number 48MM 71338663 50MM 71338664 52MM 71338665 54MM 71338666 56MM 7133866...
Reason: A manufacturing error resulted in out of specification R3 Acetabular Shells
Z-2335-2020June 17, 2020Memphis, TN
Smith & Nephew, Inc.
Class IIOngoing
smith&nephew R3 MULTI HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 48MM 71338733 50MM 71338734 52MM 71338735 54MM 71338736 56M...
Reason: A manufacturing error resulted in out of specification R3 Acetabular Shells
Z-2336-2020June 17, 2020Memphis, TN
Zimmer Biomet, Inc.
Class IITerminated
Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X40MM, Item Number 810M7540 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, post...
Reason: There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
Z-2234-2020June 10, 2020Warsaw, IN
Nobel Biocare Usa Llc
Class IITerminated
Healing Abutment Conical Connection RP 0 3.6 x 5mm, REF: 36644, UDI: 07332747034462 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting ...
Reason: Packaged dental implant healing abutments were found to contain the wrong size device.
Z-2250-2020June 10, 2020Yorba Linda, CA
Zimmer Biomet, Inc.
Class IITerminated
Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X50MM, Item Number 810M6550 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, post...
Reason: There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
Z-2221-2020June 10, 2020Warsaw, IN
Zimmer Biomet, Inc.
Class IITerminated
Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X40MM, Item Number 810M4540 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, post...
Reason: There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
Z-2212-2020June 10, 2020Warsaw, IN
Zimmer Biomet, Inc.
Class IITerminated
Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X45MM, Item Number 810M4545 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, post...
Reason: There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
Reason: The top label for dental implant may incorrectly indicate the implant length. Specifically, the label may contain 11.5mm for the length, which is shorter than the actual length of ...
Z-2207-2020June 10, 2020Yorba Linda, CA
Zimmer Biomet, Inc.
Class IITerminated
Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X45MM, Item Number 810M7545 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, post...
Reason: There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
Z-2225-2020June 10, 2020Warsaw, IN
Zimmer Biomet, Inc.
Class IITerminated
Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X50MM, Item Number 810M7550 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, post...
Reason: There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
Z-2226-2020June 10, 2020Warsaw, IN
Zimmer Biomet, Inc.
Class IITerminated
Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X35MM, Item Number 810M7535 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, post...
Reason: There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
Z-2223-2020June 10, 2020Warsaw, IN
Zimmer Biomet, Inc.
Class IITerminated
Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X35MM, Item Number 810M5535 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, post...
Reason: There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
Reason: Internal testing results showed endotoxin-related test result did not meet specifications for implantable insulin pump. If pumps have higher than allowed endotoxin levels, patient...
Z-2206-2020June 10, 2020Northridge, CA
Zimmer Biomet, Inc.
Class IITerminated
Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X50MM, Item Number 811M8550 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, poste...
Reason: There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.