Synthes Recalls SYN MESH Cages Due to Incorrect Labeling
Synthes (USA) Products LLC is recalling 9 units of SYN MESH vertebral body replacement devices because the statutory label incorrectly identifies them as 'general medical device' instead of 'specially controlled medical device.'
What this means for you
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 typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a documentation/labeling error.
Plain-English summary
Synthes (USA) Products LLC is recalling 9 units of the SYN MESH 17MM X 22MM 88MM HEIGHT (TI) vertebral body replacement device, Product Number 495-374. The recall is due to a labeling error on the statutory label, which incorrectly states 'general medical device' instead of 'specially controlled medical device.'
The affected devices are titanium implants used for the cervical, thoracic, and lumbar spine. The specific lot numbers involved are 16L4528, 23P3905, 49P1859, and M22. The source text indicates that these units were distributed internationally to Japan only.
This recall is classified as Class III by the FDA, indicating that the labeling error is unlikely to cause adverse health consequences. No specific instructions for consumers or healthcare providers are provided in the source text beyond the identification of the defect.
The recalled product
- Product
- SYNMESH 17MM X 22MM 88MM HEIGHT (TI) Product Number: 495-374 - 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 suit
- Manufacturer
- Synthes (USA) Products LLC
- Category
- Medical Device — Spinal Implants
- Hazard
- Affected units
- 9
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: 16L4528 23P3905 49P1859 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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