Recall Z-2317-2017 ยท LXH Orthopedic Manual Surgical Instrument
DePuy Orthopaedics, Inc.
DePuy Synthes various orthopedic instruments modified by U.S. Distributors These instruments are used in various orthopedic procedures
| Date | Jan 6, 2017 |
| Status | Terminated |
| 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. |
| Root cause | Vendor change control |
| Action | DePuy Synthes sent an URGENT INFORMATION RECALL NOTICE FOR INSTRUMENTS MODIFIED BY U.S. DISTRIBUTORS dated January 6, 2017, to all affected customers. . Customerss were instructed to identify all medical facilities that may have used or received the affected instruments and identify the modified instruments used at each facility. This information was to be used to generate Reconciliation Forms for each impacted Medical Facility. The Reconciliation Forms and URGENT INFORMATION RECALL NOTICE FOR INSTRUMENTS MODIFIED BY U.S. DISTRIBUTORS recall notifications were then delivered by DePu |
| Quantity | 345 |
| Distribution | Nationwide Distribution to: AZ CA IA IL IN LA MA MD ME MI MN PA VA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.