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'.
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, and the issue is a minor labeling error.
Plain-English summary
Synthes (USA) Products LLC is recalling 4 units of the END RING 17MM X 22MM LATERAL OR ANTERIOR/5 DEG (TI) (Product Number: 495.394), part of the SynMesh Cage System. The recall is due to a labeling error where the statutory label printed 'general medical device' instead of the correct classification 'specially controlled medical device'.
The affected units are identified by Lot Numbers 21P9197 and 47P8462. These devices are vertebral body replacement implants used in the cervical, thoracic, and lumbar spine. The distribution was limited to Japan.
This recall is classified as Class III by the FDA, indicating that the labeling error is unlikely to cause adverse health consequences. Consumers and healthcare providers should verify the labeling on their devices and contact the manufacturer for further instructions.
The recalled product
- 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…
- Manufacturer
- Synthes (USA) Products LLC
- Category
- Medical Device — Spinal Implant
- Hazard
- Affected units
- 4
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: 21P9197 47P8462
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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