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.'
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 minor labeling error regarding the device's regulatory classification, fitting the criteria for a Low severity score.
Plain-English summary
Synthes (USA) Products LLC is recalling 23 units of the SynMesh Cage System, specifically the End Ring 15mm Dia/0 Deg (Ti) product number 495.386. The recall is due to a labeling error where the statutory label printed 'general medical device' instead of the required 'specially controlled medical device.'
The affected units were distributed internationally to Japan only. The specific lot numbers involved in this recall are 13L9586, 35P3375, 50P2547, and H861587. The SynMesh Cage System is a vertebral body replacement device used in the cervical, thoracic, and lumbar spine.
Healthcare providers and patients should verify the lot numbers of any implanted or stored devices against the list provided. If a device matches the recalled lot numbers, users should contact Synthes (USA) Products LLC for instructions on how to proceed. This recall addresses a documentation and labeling compliance issue rather than a physical defect in the implant material.
The recalled product
- 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…
- Manufacturer
- Synthes (USA) Products LLC
- Hazard
- Affected units
- 23
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: 13L9586 35P3375 50P2547 H861587
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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