DePuy Synthes various orthopedic instruments modified by U.S. Distributors These instruments are used in various orthopedic procedures
Reported: June 14, 2017 Initiated: January 6, 2017 #Z-2317-2017
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.
Details
- Recalling Firm
- DePuy Orthopaedics, Inc.
- Units Affected
- 345
- Distribution
- Nationwide Distribution to: AZ CA IA IL IN LA MA MD ME MI MN PA VA
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
DePuy Synthes various orthopedic instruments modified by U.S. Distributors These instruments are used in various orthopedic procedures. Recalled by DePuy Orthopaedics, Inc.. Units affected: 345.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 14, 2017. Severity: Moderate. Recall number: Z-2317-2017.
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