DePuy DNP Anatomic Fracture Repair System, Locking Screw DNP Anatomic, Depuy, Warsaw, IN; REF DNPALS. The device is used
FDA device recall Z-0981-2009 · posted 2009-02-11 · Terminated
Recall details
- Recalling firm
- Depuy Orthopaedics, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- HRS
- Quantity affected
- Approx. 3,250 of all products
- Distribution
- Nationwide Distribution.
- Date initiated
- 2008-12-23
- Date posted
- 2009-02-11
- Date terminated
- 2010-10-18
- Location
- Warsaw, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DORSAL NAIL PLATE, ANATOMICAL (K052248) | Hand Innovations, LLC | 2005-09-14 |