Z-2317-2017 Class II Terminated
FDA device recall Z-2317-2017 was initiated by DePuy Orthopaedics, Inc. on January 6, 2017 and is designated Class II. 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… The recall status is terminated (terminated May 15, 2019). Affected quantity: 345.
Recall Details
- Product Type
- Devices
- Report Date
- June 14, 2017
- Initiation Date
- January 6, 2017
- Termination Date
- May 15, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 345
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.
Distribution Pattern
Nationwide Distribution to: AZ CA IA IL IN LA MA MD ME MI MN PA VA
Code Information
Unknown