Synthes SynMesh Cage System Recalled for Incorrect Statutory Labeling
Synthes (USA) Products LLC is recalling 9 units of the SynMesh Cage System because the statutory label incorrectly identifies the device as a 'general medical device' rather than a '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 and labeling error rather than a functional defect or contamination.
Plain-English summary
Synthes (USA) Products LLC is recalling 9 units of the SynMesh Cage System, specifically the End Ring 17mm x 22mm Lateral or Anterior/0 Deg (Ti) (Product Number 495.392). The recall was initiated because the statutory label on the device incorrectly states '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 43P3070, 45P9029, 48P09506, and H873508. 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 labeling defect.
The recalled product
- Product
- END RING 17MM X 22MM LATERAL OR ANTERIOR/0 DEG (TI) Product Number: 495.392 - 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 th
- 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: 43P3070 45P9029 48P09506 H873508
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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