Reported Jul 29, 2020 · Terminated
TRIGEN, Intramedullary nail - Product Usage: is intended to provide resistance for screw back-out. It provides…
Smith & Nephew, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Smith & Nephew, Inc. · 1450 E Brooks Rd · Memphis, TN · 38116-1804
Is this the product you have?
- TRIGEN
- Intramedullary nail - Product Usageis intended to provide resistance for screw back-out. It provides additional friction to help hold the screws in place
- Lot codes and dates
- Model71655139
- Lot19BM13592A
- Amount recalled
- 12 units
Why it was recalled
A manufacturing error which resulted in the re-sterilization of the ultra-high-molecular-weight polyethylene (UHMWPE) sleeve.
This product could cause temporary or reversible health problems — stop using it.
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