Synthes Medical Nail Wraps Recalled for Insufficient Multi-Use Testing
Synthes (USA) Products LLC is recalling specific tibial and intramedullary nail wraps because they lack sufficient testing to be considered multi-use items.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a lack of testing for multi-use, which is a precautionary regulatory issue rather than a reported acute health threat.
Plain-English summary
Synthes (USA) Products LLC is recalling 1,487 units of Synthes Tibial Nail Wrap Holds 11 Nails and Synthes Intramedullary Nail Wrap Holds 10 Nails. These devices are intended to be used as protective sheaths for specific intramedullary nails during steam sterilization by hospitals. The recall affects all lots of part numbers 900.50 and 900.51.
The recall was initiated because the nail wraps are designed for single use for nail sterilization but do not have sufficient testing to be considered multi-use items. The agency classifies this as a Class II recall.
The affected products were distributed worldwide, including the United States (including Puerto Rico), Canada, Switzerland, and New Zealand. Hospitals and medical facilities should stop using these specific nail wraps and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Synthes Tibial Nail Wrap Holds 11 Nails and Synthes Intramedullary Nail Wrap Holds 10 Nails; the Nail Wrap is intended to be used as a protective sheath specifically for Universal Femoral Nails, Universal Tibial Nails, Unreamed Tibial Nail, and the Stainless Steel Tibial Nail…
- Manufacturer
- Synthes (USA) Products LLC
- Affected units
- 1,487
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 (2)
- all lots of part numbers: 900.50
- 900.51
Distribution
Distributed in 1 state:
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