—#77098

Product

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.

FDA product code: HRS — Plate, Fixation, Bone
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K052248
Affected lot / code info: All lots.

Why it was recalled

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 (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Depuy Orthopaedics, Inc.
Address: 700 Orthopaedic Dr, Warsaw, Indiana 46582-3994

Distribution

Distribution pattern: Nationwide Distribution.

Timeline

Recall initiated: 2008-12-23
Posted by FDA: 2009-02-11
Terminated: 2010-10-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #77098. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.