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

Recall Z-2335-2020 — smith&nephew R3 MULTI HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Sizes REF/product number 48MM 71338663 50MM 71338664 52MM 71338665 54MM 71338666 56MM 71338667 58MM 71338668 Orthopedic implant component.

U.S. FDA — Device Enforcement · United States · 2020-04-22 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2335-2020
Date of alert
2020-04-22
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Smith & Nephew, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
71338663
Reported risk: A manufacturing error resulted in out of specification R3 Acetabular Shells
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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