Reason: Due to an extra digit being inadvertently added to the serial number of a subset of implantable pulse generators, they become not compatible with therapy programmers with software ...
Z-0462-2021November 25, 2020Houston, TX
Merz North America, Inc.
Class IIOngoing
COAPTITE Injectable Implant, injectable, sterile, non-pyrogenic implant composed of spherical particles (75-125 microns in diameter of calcium hydroxylapatite (CaHA), suspended in aqueous based gel ca...
Reason: The Instructions for Use (IFU) updated 03/02/2020 does not match data listed in the post-approval study.
Z-0401-2021November 25, 2020Franksville, WI
XTANT Medical
Class IIITerminated
XTANT Medical, ## mm x ## mm x # mm x # ,Lordotic/Packaged InTice - C, Sterile R, Single Use Only, for the following Reference numbers/ Primary DI Number/Material Grade on Label: Ref: X098-0106-STR ...
Reason: Cervical Implants contain a label that incorrectly identifies the grade of titanium used.
Z-0429-2021November 18, 2020Belgrade, MT
Synthes (USA) Products LLC
Class IIITerminated
SYNMESH 15MM DIA 88MM HEIGHT (TI) Product Number: 495.366 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints...
Reason: Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
Z-0405-2021November 11, 2020West Chester, PA
Synthes (USA) Products LLC
Class IIITerminated
END RING 15MM DIA/0 DEG (TI) Product Number: 495.386 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and h...
Reason: Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
Z-0410-2021November 11, 2020West Chester, PA
Synthes (USA) Products LLC
Class IIITerminated
END RING 17MM X 22MM LATERAL OR ANTERIOR/0 DEG (TI) Product Number: 495.392 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in ...
Reason: Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
Z-0411-2021November 11, 2020West Chester, PA
Synthes (USA) Products LLC
Class IIITerminated
STANDARD RING 22MM X 28MM (TI) Product Number: 495-406 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and...
Reason: Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
Z-0416-2021November 11, 2020West Chester, PA
Synthes (USA) Products LLC
Class IIITerminated
DePuy Synthes SYNMESH 10MM DIA 18MM HEIGHT (TI) Product Number: 495.344 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in vario...
Reason: Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
Z-0403-2021November 11, 2020West Chester, PA
Synthes (USA) Products LLC
Class IIITerminated
END RING 17MM X 22MM LATERAL OR ANTERIOR/5 DEG (TI) Product Number: 495.394 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in ...
Reason: Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
Z-0412-2021November 11, 2020West Chester, PA
Synthes (USA) Products LLC
Class IIITerminated
END RING 12MM DIA/0 DEG (TI) Product Number: 495.385 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and h...
Reason: Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
Z-0409-2021November 11, 2020West Chester, PA
Synthes (USA) Products LLC
Class IIITerminated
SYNMESH 17MM X 22MM 88MM HEIGHT (TI) Product Number: 495-374 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footpri...
Reason: Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
Z-0406-2021November 11, 2020West Chester, PA
Synthes (USA) Products LLC
Class IIITerminated
3.0MM LOCKING SCREW LOW PROFILE (TI) Product Number: 495-491 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footpri...
Reason: Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
Z-0417-2021November 11, 2020West Chester, PA
Synthes (USA) Products LLC
Class IIITerminated
SYNMESH 12MM DIA 88MM HEIGHT (TI) Product Number: 495.357 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints...
Reason: Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
Z-0404-2021November 11, 2020West Chester, PA
Synthes (USA) Products LLC
Class IIITerminated
SYNMESH¿ 22MM X 28MM 88MM HEIGHT (TI) Product Number: 495.379 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footp...
Reason: Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
Z-0407-2021November 11, 2020West Chester, PA
Synthes (USA) Products LLC
Class IIITerminated
END RING 22MM X 28MM LATERAL OR ANTERIOR/5 DEG (TI) Product Number: 495-398 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in ...
Reason: Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
Z-0414-2021November 11, 2020West Chester, PA
Synthes (USA) Products LLC
Class IIITerminated
END RING 10MM DIA/0 DEG (TI) Product Number: 495.384 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and h...
Reason: Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
Z-0408-2021November 11, 2020West Chester, PA
Synthes (USA) Products LLC
Class IIITerminated
STANDARD RING 17MM X 22MM (TI) Product Number: 495-405 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and ...
Reason: Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
Z-0415-2021November 11, 2020West Chester, PA
Synthes (USA) Products LLC
Class IIITerminated
END RING 22MM X 28MM LATERAL OR ANTERIOR/0 DEG (TI) Product Number: 495-396 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in ...
Reason: Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
Z-0413-2021November 11, 2020West Chester, PA
Zimmer Biomet, Inc.
Class IITerminated
Dual Mobility Vivacit-E Bearing, Model Number 110031009
Reason: The outer package is labeled as a Size C 38 mm, however, the implant inside the package is a Size E 42 mm.
Z-0057-2021October 14, 2020Warsaw, IN
Encore Medical, LP
Class IIOngoing
RSP Standard HUMERAL SOCKET INSERT, 44MM, HXe-Plus, Part No. 509-00-044
Reason: Product may be mislabeled with the size etched onto products differing from the size information shown on patient sticker labels. Risks associated with this issue may include the S...
Z-3021-2020October 7, 2020Austin, TX
Encore Medical, LP
Class IIOngoing
RSP Standard HUMERAL SOCKET INSERT, 40 MM plus 4MM, HXe-Plus, Part No. 509-00-440
Reason: Product may be mislabeled with the size etched onto products differing from the size information shown on patient sticker labels. Risks associated with this issue may include the S...
Z-3022-2020October 7, 2020Austin, TX
MicroPort Orthopedics Inc.
Class ITerminated
PROFEMUR Neck Extra Long Titanium, Catalog Numbers: PHA01206, PHA01236, PHA01256. Hip prosthesis component
Reason: MicroPort Orthopedics Inc. states that there have been reports of fractures of the long and extra-long Titanium modular femoral neck component after implantation. Worldwide there ...
Z-2942-2020September 30, 2020Arlington, TN
Sorin Group Italia S.r.l.
Class IITerminated
Perceval Single Use Accessory Kit, Size S, REF: ICV1345, Sterile EO, Rx Only, CE, UDI: 8022057015204 - Product Usage: he Dual Collapser is a component of the Perceval single use accessory kits used ...
Reason: LivaNova received complaints indicating the impossibility to collapse Perceval valve during procedure. The Dual Collapser is a component of the Perceval single use accessory kits u...
Z-2984-2020September 30, 2020Saluggia, N/A
MicroPort Orthopedics Inc.
Class ITerminated
PROFEMUR Neck Long Titanium, Catalog Numbers: PHA01204, PHA01214, PHA01224, PHA01234, PHA01244, PHA01254, PHA01264. Hip prosthesis component.
Reason: MicroPort Orthopedics Inc. states that there have been reports of fractures of the long and extra-long Titanium modular femoral neck component after implantation. Worldwide there ...
Z-2941-2020September 30, 2020Arlington, TN
Sorin Group Italia S.r.l.
Class IITerminated
Perceval Single Use Accessory Kit, Size M, REF: ICV1346, Sterile EO, Rx Only, CE, UDI: 8022057015228 - Product Usage: he Dual Collapser is a component of the Perceval single use accessory kits used to...
Reason: LivaNova received complaints indicating the impossibility to collapse Perceval valve during procedure. The Dual Collapser is a component of the Perceval single use accessory kits u...