Synthes SynMesh Cage System Recalled for Incorrect Labeling
Synthes (USA) Products LLC is recalling 4 units of the SynMesh Cage System because the statutory label incorrectly identifies 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.
Plain-English summary
Synthes (USA) Products LLC is recalling 4 units of the SynMesh Cage System, specifically the End Ring 22mm x 28mm Lateral or Anterior/5 Deg (Ti) (Product Number 495-398). 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 units are identified by Lot Numbers 13L6742 and 14L2479. The distribution pattern for these units was limited to Japan. The SynMesh Cage System is a vertebral body replacement device used for the cervical, thoracic, and lumbar spine.
The source text does not provide specific instructions for consumers or healthcare providers regarding the next steps for this recall.
The recalled product
- Product
- END RING 22MM X 28MM LATERAL OR ANTERIOR/5 DEG (TI) Product Number: 495-398 - 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…
- Manufacturer
- Synthes (USA) Products LLC
- Hazard
- Affected units
- 4
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: 13L6742 14L2479
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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