Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1317-2018 — D-RAD Self-Tapping Locking Screw intended for the fixation of fractures involving the distal radius. smith&nephew D-RAD 2.4MM X 10MM S-T LOCKING SCREW, REF 74692410, QTY (1), STERILE R

U.S. FDA — Device Enforcement · United States · 2018-03-07 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1317-2018
Date of alert
2018-03-07
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Smith & Nephew, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
74692410
Reported risk: One lot of D-RAD Self-Taping Locking Screws used with the Distal Radius Fracture Kit were machined out of specification. Screws measured over tolerance within the head thread form by 0.002-0.003 inch.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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