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.
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 the rubric defines as unlikely to cause adverse health consequences. The issue is a documentation and labeling error with no reported harm.
Plain-English summary
Synthes (USA) Products LLC is recalling 16 units of the END RING 10MM DIA/0 DEG (TI) vertebral body replacement device, part of the SYNMESH CAGE SYSTEM. The recall involves specific lot numbers 10L6451 and 13L9584. These titanium implants are designed for the cervical, thoracic, and lumbar spine.
The recall was initiated because the statutory label on the devices incorrectly printed 'general medical device' instead of 'specially controlled medical device.' This is a labeling error regarding the regulatory classification of the product.
The affected units were distributed internationally to Japan only. The source text does not report any illnesses, injuries, or deaths associated with this recall.
The recalled product
- 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…
- Manufacturer
- Synthes (USA) Products LLC
- Hazard
- Affected units
- 16
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: 10L6451 13L9584
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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