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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 28, 2021 · Data as of Sep 19, 4:50 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.