Home / Recalls / Medical Devices
DePuy Orthopaedics, Inc. recalls DePuy Synthes various orthopedic instruments modified by U.S. Distributors These instruments are used in various orth
Recalled June 14, 2017 · FDA recall Z-2317-2017 · DePuy Orthopaedics
Hazard
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. · FDA Class II
Units
345
Sold at
Nationwide Distribution to: AZ CA IA IL IN LA MA MD ME MI MN PA VA
Description
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.
Product
DePuy Synthes various orthopedic instruments modified by U.S. Distributors These instruments are used in various orthopedic procedures
Manufacturer(s)
DePuy Orthopaedics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →