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.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a documentation and labeling error rather than a functional defect or contamination.
Plain-English summary
Synthes (USA) Products LLC is recalling 6 units of the END RING 22MM X 28MM LATERAL OR ANTERIOR/0 DEG (TI) vertebral body replacement device, part of the SynMesh Cage System. The recall was initiated because the statutory label on the device incorrectly printed 'general medical device' instead of 'specially controlled medical device.'
The affected units are identified by Lot Numbers 17P4887 and 32P3937. The distribution pattern for these units was limited to Japan. The device is a titanium implant used for vertebral body replacement in the cervical, thoracic, and lumbar spine.
Consumers and healthcare providers should stop using the affected devices and contact Synthes (USA) Products LLC for further instructions regarding the recall.
The recalled product
- 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…
- Manufacturer
- Synthes (USA) Products LLC
- Hazard
- Affected units
- 6
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Numbers: 17P4887 32P3937
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 15 recalled by Synthes (USA) Products LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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