FDA-Device2017-06-14Class II
DePuy Synthes various orthopedic instruments modified by U.S. Distributors These instruments are used in various orthopedic procedures
DePuy Orthopaedics, Inc.
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.
Sold states
Nationwide Distribution to: AZ CA IA IL IN LA MA MD ME MI MN PA VA
Affected count
345
Manufactured in
700 Orthopaedic Dr, N/A, Warsaw, IN, United States
Products
DePuy Synthes various orthopedic instruments modified by U.S. Distributors These instruments are used in various orthopedic procedures
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2317-2017Don't want to check this manually?
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