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

Recall Z-2521-2018 — CORAIL Cementless Femoral Stem HA Coated Standard Size 11, Catalog No. 3L92511

U.S. FDA — Device Enforcement · United States · 2018-06-21 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2521-2018
Date of alert
2018-06-21
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
DePuy Orthopaedics, Inc.
Product category
device
Product type
Devices
Reported risk: Two lots of femoral stems were labeled as Size 11. However, they are actually Size 12. Potential adverse effects include poor joint mechanics, improper fit, loosening, and additional surgical procedure to correct. It may also result in an intraoperative fracture which could represent a surgical delay and additional procedures.
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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