Synthes Vertebral Body Replacement Device Recalled for Labeling Error
Synthes (USA) Products LLC is recalling 7 units of the Standard Ring 17mm x 22mm (Ti) vertebral body replacement device due to an incorrect statutory label.
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. The issue is a minor labeling error with no reported injuries.
Plain-English summary
Synthes (USA) Products LLC is recalling 7 units of the Standard Ring 17mm x 22mm (Ti) vertebral body replacement device, Product Number 495-405. The recall involves specific lot numbers 25P6483 and 3L27511. These devices are titanium implants used for the cervical, thoracic, and lumbar spine.
The recall was initiated because the statutory label on the device incorrectly printed 'general medical device' instead of 'specially controlled medical device.' This is a labeling error regarding the regulatory classification of the product.
The affected units were distributed internationally to Japan only. No injuries or illnesses have been reported in connection with this recall. Healthcare providers and distributors in Japan should stop using the affected units and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- STANDARD RING 17MM X 22MM (TI) Product Number: 495-405 - 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
- Hazard
- Affected units
- 7
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: 25P6483 3L27511
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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