Reported Apr 24, 2013 · Terminated

TRIGEN (TM) L-P SCREW, 4.5 MM X 37.5 MM, TI-6AL-4V, QTY: (1), STERILE R, REF 71645437, Smith & Nephew, Inc. Memphis, TN…

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

Is this the product you have?

    • TRIGEN (TM) L-P SCREW
    • 4.5 MM X 37.5 MM
    • TI-6AL-4V
  • QTY(1), STERILE R, REF 71645437, Smith & Nephew, Inc. Memphis, TN 38116 USA orthopedic surgery
Lot codes and dates
  • Lot Number 12FM12182
Amount recalled
23 units

Where it was sold

Why it was recalled

One batch of 4.5 mm diameter Trigen Low-Profile Bone Screws were incorrectly anodized with a gold coating (indicating a 5 mm diameter) instead of a gray coating (indicating a 4.5 mm diameter).

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 Aug 16, 2019 · Data as of Sep 19, 4:52 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.