Synthes SynMesh Cage System Recalled for Incorrect Labeling
Synthes (USA) Products LLC is recalling 6 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 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 and labeling error rather than a physical defect or contamination.
Plain-English summary
Synthes (USA) Products LLC is recalling 6 units of the SynMesh Cage System, specifically the Standard Ring 22mm x 28mm (Ti) (Product Number 495-406). The recall was initiated because the statutory label on the device incorrectly printed 'general medical device' instead of the required 'specially controlled medical device.'
The affected units are vertebral body replacement devices intended for use in the cervical, thoracic, and lumbar spine. The specific lot numbers involved in this recall are 19P7847, 20P1747, 21P3268, and H865134.
According to the source text, the distribution of these units was limited to Japan. Healthcare providers and facilities in Japan should verify their inventory for these specific lot numbers and contact the manufacturer for further instructions.
The recalled product
- Product
- STANDARD RING 22MM X 28MM (TI) Product Number: 495-406 - 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
- Category
- Medical Device — Spinal Implants
- Hazard
- Affected units
- 6
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: 19P7847 20P1747 21P3268 H865134
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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