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

Recall Z-2332-2020 — smith&nephew R3 ZERO HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71332242 46MM 71332246 48MM 71332248 50MM 71332250 52MM 71332252 54MM 71332254 56MM 71332256 58MM 71332258 60MM 71332260 62MM 71332262 64MM 71332264

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-2332-2020
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): 71332242

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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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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