Smith & Nephew Recalls TRIGEN Intramedullary Nail Sleeves Due to Sterilization Error
Smith & Nephew is recalling 12 TRIGEN intramedullary nail sleeves because a manufacturing error led to improper re-sterilization of the polyethylene material.
What this means for you
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, and the hazard is a manufacturing/sterilization error without confirmed harm, fitting the 'Moderate' criteria for low-risk contamination or precautionary recalls.
Plain-English summary
Smith & Nephew, Inc. is recalling 12 units of the TRIGEN intramedullary nail sleeve, model 71655139, lot 19BM13592A. The product is intended to provide resistance for screw back-out and additional friction to help hold screws in place. The recall is due to a manufacturing error that resulted in the re-sterilization of the ultra-high-molecular-weight polyethylene (UHMWPE) sleeve.
The affected units were distributed internationally in Brazil, Colombia, and the United Arab Emirates. The source text does not specify the number of patients affected or report any illnesses or injuries associated with the use of these devices.
Healthcare providers and patients who have used or are using these specific units should contact Smith & Nephew for further instructions on how to proceed. The recall is classified as Class II by the FDA, indicating that use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- TRIGEN, Intramedullary nail - Product Usage: is intended to provide resistance for screw back-out. It provides additional friction to help hold the screws in place.
- Manufacturer
- Smith & Nephew, Inc.
- 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)
- Model: 71655139 Lot: 19BM13592A
Distribution
Distribution scope not specified by the agency.
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