Synthes SynMesh Cage System Recalled for Incorrect Statutory Labeling
Synthes (USA) Products LLC is recalling 18 units of the SynMesh Cage System because the statutory label incorrectly identified the device as a 'general medical device' instead of 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 'Low' severity criteria for documentation issues.
Plain-English summary
Synthes (USA) Products LLC is recalling 18 units of the END RING 12MM DIA/0 DEG (TI) (Product Number 495.385), part of the SynMesh Cage System. This vertebral body replacement device is used for the cervical, thoracic, and lumbar spine. The recall is due to a labeling error on the statutory label, which incorrectly 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 20P5299, 20P5316, 20P5321, 35P3361, and H861583. The error is a documentation and labeling issue that does not indicate a defect in the physical device itself.
Healthcare providers and facilities that have received these specific units should stop using them and contact Synthes (USA) Products LLC for instructions on how to return or replace the devices. Consumers should not use these devices if they have them in their possession.
The recalled product
- Product
- END RING 12MM DIA/0 DEG (TI) Product Number: 495.385 - 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
- 18
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: 20P5299 20P5316 20P5321 35P3361 H861583
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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