Synthes SYNMesh Vertebral Body Replacement Devices Recalled for Labeling Error
Synthes (USA) Products LLC is recalling 12 units of SYNMesh vertebral body replacement devices because the statutory label incorrectly identifies them as 'general medical devices' instead of 'specially controlled medical devices.'
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 by definition is unlikely to cause adverse health consequences, and the issue is a minor labeling error.
Plain-English summary
Synthes (USA) Products LLC is recalling 12 units of SYNMesh 12MM DIA 88MM HEIGHT (TI) vertebral body replacement devices. The recall is due to a labeling error on the statutory label, which incorrectly states 'general medical device' instead of the required 'specially controlled medical device.'
The affected devices are titanium implants used for the cervical, thoracic, and lumbar spine. The specific lot numbers involved are 15L4249, 50P8888, 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. No injuries or illnesses have been reported in connection with this recall.
The recalled product
- Product
- SYNMESH 12MM DIA 88MM HEIGHT (TI) Product Number: 495.357 - 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…
- Manufacturer
- Synthes (USA) Products LLC
- Hazard
- Affected units
- 12
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: 15L4249 50P8888 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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