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

Recall Z-2317-2017 — DePuy Synthes various orthopedic instruments modified by U.S. Distributors These instruments are used in various orthopedic procedures

U.S. FDA — Device Enforcement · United States · 2017-01-06 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2317-2017
Date of alert
2017-01-06
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
DePuy Orthopaedics, Inc.
Product category
device
Product type
Devices
Reported risk: Products were made outside of Quality System Regulation, and potentially outside of premarket submission (510k/PMA) for certain devices. The safety or effectiveness of these devices cannot be assured.
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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