Synthes SYNMesh Vertebral Body Replacement Recalled for Labeling Error
Synthes (USA) Products LLC is recalling 5 units of SYNMesh vertebral body replacement devices because the statutory label incorrectly identifies them as general medical devices.
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 5 units of SYNMesh 22MM X 28MM 88MM HEIGHT (TI) vertebral body replacement devices. The recall is due to a labeling error on the statutory label, which incorrectly identifies the product as a 'general medical device' instead of a 'specially controlled medical device.'
The affected product is a titanium implant used for the cervical, thoracic, and lumbar spine. The specific lot numbers involved are 10L8490, 17P3848, and M22. The distribution pattern for these units was limited to Japan.
This recall is classified as Class III by the FDA, indicating that the labeling error is unlikely to cause adverse health consequences. Consumers and healthcare providers should contact the manufacturer for further instructions regarding the affected units.
The recalled product
- Product
- SYNMESH¿ 22MM X 28MM 88MM HEIGHT (TI) Product Number: 495.379 - 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 sui
- Manufacturer
- Synthes (USA) Products LLC
- Hazard
- Affected units
- 5
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: 10L8490 17P3848 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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