FDAFDA · Food and drugs·Recall number Z-2317-2017
DePuy Synthes various orthopedic instruments modified by U.S. Distributors These instruments are used in various orthopedic procedures
Published June 14, 2017 · Recall initiated: January 6, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- DePuy Orthopaedics, Inc.
- Distributor
- Nationwide Distribution to: AZ CA IA IL IN LA MA MD ME MI MN PA VA
- Lot
- Unknown
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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