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

Recall Z-0350-2017 — TANDEM (TM) COCR SHELL UHMWPE LINER BIPOLAR, REF NUMBERS: 71322040, 71322041, 71322042, 71322043, 71322044, 71322045, 71322046, 71322047, 71322048, 71322049, 71322050, 71322051, 71322052, 71322053, 71322054, 71322055, 71322057

U.S. FDA — Device Enforcement · United States · 2016-08-29 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0350-2017
Date of alert
2016-08-29
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Smith & Nephew, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
71322040
Reported risk: Some Bipolar shells were manufactured with an out of specification retainer groove.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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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.