FDA (Devices) recall action 86545

Synthes (USA) Products LLC recalled 15 products on 2020-11-11

The FDA (Devices) publishes a recall like this one as 15 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 15 pages.

Products: 15
Announced: 2020-11-11
Critical: 0
Units: 164

Why these products were recalled

Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–15 of 15

LowFDA (Devices)··2020-11-11
DePuy Synthes SYNMESH CAGE System Recalled for Incorrect Labeling
Synthes (USA) Products LLC is recalling 10 units of DePuy Synthes SYNMESH CAGE System devices distributed in Japan due to incorrect statutory labeling.
Product
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 various footprints and heights enable the surgeon to choose the configuration that is
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0 states
LowFDA (Devices)··2020-11-11
Synthes SynMesh Cages Recalled for Incorrect Statutory Labeling
Synthes (USA) Products LLC is recalling 18 units of SynMesh Cages due to incorrect statutory labeling. The devices were distributed only in Japan.
Product
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 footprints and heights enable the surgeon to choose the configuration that is best suit
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0 states
LowFDA (Devices)··2020-11-11
Synthes SYN MESH Vertebral Body Replacement Recalled for Labeling Error
Synthes (USA) Products LLC is recalling 17 units of SYN MESH vertebral body replacement devices because the statutory label incorrectly identifies them as 'general medical devices' instead of 'specially controlled medical devices.'
Product
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 and heights enable the surgeon to choose the configuration that is best suited
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0 states
LowFDA (Devices)··2020-11-11
Synthes SynMesh Cage System Recalled for Incorrect Labeling
Synthes (USA) Products LLC is recalling 4 units of the SynMesh Cage System because the statutory label incorrectly stated 'general medical device' instead of 'specially controlled medical device'.
Product
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 various footprints and heights enable the surgeon to choose the configuration th
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0 states
LowFDA (Devices)··2020-11-11
Synthes SynMesh Cage System Recalled for Incorrect Labeling
Synthes (USA) Products LLC is recalling 6 units of the SynMesh Cage System because the statutory label incorrectly identified the device as a 'general medical device' instead of a 'specially controlled medical device.'
Product
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 heights enable the surgeon to choose the configuration that is best suited to t
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0 states
LowFDA (Devices)··2020-11-11
Synthes SYNMesh Vertebral Body Replacement Devices Recalled for Labeling Error
Synthes (USA) Products LLC is recalling 12 units of SYNMesh vertebral body replacement devices because the statutory label incorrectly identifies them as 'general medical devices' instead of 'specially controlled medical devices.'
Product
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 and heights enable the surgeon to choose the configuration that is best suited
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0 states
LowFDA (Devices)··2020-11-11
Synthes SynMesh Cages Recalled for Incorrect Statutory Labeling
Synthes (USA) Products LLC is recalling 16 SynMesh Cages distributed in Japan because the statutory label incorrectly identified them as general medical devices.
Product
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 heights enable the surgeon to choose the configuration that is best suited to the
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0 states
LowFDA (Devices)··2020-11-11
Synthes SYNMesh Vertebral Body Replacement Recalled for Labeling Error
Synthes (USA) Products LLC is recalling 5 units of SYNMesh vertebral body replacement devices because the statutory label incorrectly identifies them as general medical devices.
Product
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 footprints and heights enable the surgeon to choose the configuration that is best sui
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0 states
LowFDA (Devices)··2020-11-11
Synthes SynMesh Cage System Recalled for Incorrect Statutory Labeling
Synthes (USA) Products LLC is recalling 9 units of the SynMesh Cage System because the statutory label incorrectly identifies the device as a 'general medical device' rather than a 'specially controlled medical device.'
Product
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 various footprints and heights enable the surgeon to choose the configuration th
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0 states
LowFDA (Devices)··2020-11-11
Synthes SynMesh Cage System Recalled for Incorrect Statutory Labeling
Synthes (USA) Products LLC is recalling 23 units of the SynMesh Cage System because the statutory label incorrectly identifies the device as a 'general medical device' rather than a 'specially controlled medical device.'
Product
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 heights enable the surgeon to choose the configuration that is best suited to the
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0 states
LowFDA (Devices)··2020-11-11
Synthes SynMesh Cage System Recalled for Incorrect Labeling
Synthes (USA) Products LLC is recalling 4 units of the SynMesh Cage System because the statutory label incorrectly identifies the device as a 'general medical device' instead of a 'specially controlled medical device.'
Product
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 various footprints and heights enable the surgeon to choose the configuration th
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0 states
LowFDA (Devices)··2020-11-11
Synthes Vertebral Body Replacement Device Recalled for Labeling Error
Synthes (USA) Products LLC is recalling 7 units of the Standard Ring 17mm x 22mm (Ti) vertebral body replacement device due to an incorrect statutory label.
Product
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 heights enable the surgeon to choose the configuration that is best suited to th
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0 states
LowFDA (Devices)··2020-11-11
Synthes Recalls SYN MESH Cages Due to Incorrect Labeling
Synthes (USA) Products LLC is recalling 9 units of SYN MESH vertebral body replacement devices because the statutory label incorrectly identifies them as 'general medical device' instead of 'specially controlled medical device.'
Product
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 footprints and heights enable the surgeon to choose the configuration that is best suit
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0 states
LowFDA (Devices)··2020-11-11
Synthes SynMesh Cage System Recalled for Incorrect Statutory Labeling
Synthes (USA) Products LLC is recalling 18 units of the SynMesh Cage System because the statutory label incorrectly identified the device as a 'general medical device' instead of a 'specially controlled medical device.'
Product
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 heights enable the surgeon to choose the configuration that is best suited to the
Category
Distribution
0 states
LowFDA (Devices)··2020-11-11
Synthes SynMesh Cage System Recalled for Incorrect Statutory Labeling
Synthes (USA) Products LLC is recalling 6 units of the SynMesh Cage System because the statutory label incorrectly identifies the device as a general medical device.
Product
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 various footprints and heights enable the surgeon to choose the configuration th
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0 states