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

Recall Z-0092-2018 — smith&nephew LEGION L-WEDGE, 10 MM DIS X 5 MM POS, SIZE 4, SCREW-ON FEMORAL WEDGE, REF 71421733, STERILE R Product The Revision Knee System Components are indicated for rheumatoid arthritis; post-traumatic arthritis; osteoarthritis; degenerative arthritis; and failed osteotomies, hemiarthroplasti

U.S. FDA — Device Enforcement · United States · 2017-09-14 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0092-2018
Date of alert: 2017-09-14
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Smith & Nephew, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 71421733

Reported risk: The Legion Screw-on Wedge Size 4 contained 5MM screws instead of the required 10MM screw.

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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