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

Recall Z-0878-2020 — LEGION AP Cutting Block Size 4, REF 71434409; LEGION AP Cutting Block Size 6, REF 71434411; LEGION AP Cutting Block Size 7, REF 71434412; LEGION AP Cutting Block Size 8, REF 71434413. (Orthopaedic manual surgical instrument).

U.S. FDA — Device Enforcement · United States · 2019-12-16 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0878-2020
Date of alert
2019-12-16
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Smith & Nephew, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
71434409
Reported risk: Multiple lots of LEGION AP Femoral Cutting Blocks were manufactured with an oversize green plunger hole and therefore do not meet their design specifications.
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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