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 SCREW4.5 MM X 37.5 MMTI-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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