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Smith & Nephew Inc recalls 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
Recalled April 24, 2013 · FDA recall Z-1132-2013 · Smith & Nephew
Hazard
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). · FDA Class II
Units
23 units
Sold at
Nationwide Distribution including CA, FL, GA, MA, MI, NC, SC, OH, and MO.
Description
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).
Product
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
Manufacturer(s)
Smith & Nephew Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →