FDA-Device2013-04-24Class II
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
Smith & Nephew Inc
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).
Sold states
Nationwide Distribution including CA, FL, GA, MA, MI, NC, SC, OH, and MO.
Affected count
23 units
Manufactured in
1450 E. Brooks Rd, N/A, Memphis, TN, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1132-2013Don't want to check this manually?
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