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

Recall Z-1756-2015 — MCK Maximum Congruent Knee System, BIOMET FINNED PRI STEM 40MM; 80 x 10MM; 80 x 12.5 MM; 80 x 15 MM Knee joint replacement prostheses components include femoral, tibial, and patellar components.

U.S. FDA — Device Enforcement · United States · 2015-04-16 · Class III

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1756-2015
Date of alert: 2015-04-16
Country / jurisdiction: United States
Risk level: Class III
Risk type: recall
Brand: Biomet, Inc.
Product category: device
Product type: Devices

Reported risk: Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN (Global Trade Identification Number) codes.

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.

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.

Recall Z-1756-2015 — MCK Maximum Congruent Knee System, BIOMET FINNED PRI STEM 40MM; 80 x 10MM; 80 x 12.5 MM; 80 x 15 MM Knee joint replacement prostheses components include femoral, tibial, and patellar components.

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