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.
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 10 units of the DePuy Synthes SYNMESH 10MM DIA 18MM HEIGHT (TI) vertebral body replacement device. The recall is limited to units distributed internationally to Japan only. The specific lot numbers affected are H651313, H667046, and M22.
The recall was initiated because the statutory label on the SYNMESH CAGE SYSTEM incorrectly printed 'general medical device' instead of the required 'specially controlled medical device.' This is a labeling error regarding the device's regulatory classification.
The source text does not specify actions for consumers or patients, as the distribution was limited to Japan. No illnesses or injuries are reported in the source text.
The recalled product
- 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…
- Manufacturer
- Synthes (USA) Products LLC
- Hazard
- Affected units
- 10
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: H651313 H667046 M22
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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