DePuy Synthes various orthopedic instruments modified recall
DePuy Synthes various orthopedic instruments modified by U.S. Distributors These instruments are used in various orthopedic procedures
Why was DePuy Synthes various orthopedic instruments modified 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Unknown
- Product
- DePuy Synthes various orthopedic instruments modified by U.S. Distributors These instruments are used in various orthopedic procedures
- Recalling firm
- DePuy Orthopaedics, Inc.
- Quantity
- 345
- Distribution
- Nationwide Distribution to: AZ CA IA IL IN LA MA MD ME MI MN PA VA
- Recall date
- June 14, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)