Recall Z-2317-2017— DePuy Orthopaedics, Inc.

Name: FDA recall Z-2317-2017
Creator: U.S. Food and Drug Administration
Published: 2017-01-06

Class II · Terminated

Class II FDA medical device recall by DePuy Orthopaedics, Inc., initiated 2017-01-06, terminated 2019-05-15. FDA's recall record names no specific 510(k) clearance for this event. Product: DePuy Synthes various orthopedic instruments modified by U.S. Distributors These instruments are used in various orthopedic procedures. Reason: 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..

Recalling firm: DePuy Orthopaedics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-01-06
Terminated: 2019-05-15
Firm location: Warsaw, IN, United States

Product description

DePuy Synthes various orthopedic instruments modified by U.S. Distributors These instruments are used in various orthopedic procedures

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.