Smith & Nephew, Inc. recalls TRIGEN, Intramedullary nail - Product Usage: is intended to provide resistance for screw back-out. It provides addition…
- Recall date
- June 24, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2685-2020
- FDA classification
- Class II
- Brand / firm
- Smith & Nephew, Inc.
- Sold / distributed
- International distribution in the countries of Brazil, Colombia and United Arab Emirates.
Why it was recalled
A manufacturing error which resulted in the re-sterilization of the ultra-high-molecular-weight polyethylene (UHMWPE) sleeve.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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