Recall Z-0984-2009 ยท HRS Plate, Fixation, Bone
Depuy Orthopaedics, Inc.
DePuy DNP Anatomic Fracture Repair System, DNP Anatomic Right, Depuy, Warsaw, IN; REF DNPAR. The device is used in the treatment of fractures and osteotomies of the distal radius.
| Date | Feb 11, 2009 (initiated Dec 23, 2008) |
| Status | Terminated |
| Reason | The DNP nail plate may not attach to the alignment guide (jig) instrument, making it difficult to insert the nail plate into position or to drill needed holes accurately. |
| Root cause | Device Design |
| Action | The firm's sales force was instructed via "Urgent Device Correction" letter issued December 29, 2008 to inspect all of these instruments in their possession, and those instruments at their hospital customers, and to leave a copy of the letter with each hospital customer who has the instruments on site. The letter describes the issue and corrective actions for customers. Please direct questions about this recall to Depuy Orthopaedics, Inc. at 888-783-7156. |
| Quantity | Approx. 3,250 of all products |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052248 | DORSAL NAIL PLATE, ANATOMICAL Hand Innovations, LLC, Sep 14, 2005 |