Z-0981-2009

DePuy DNP Anatomic Fracture Repair System, Locking Screw DNP Anatomic, Depuy, Warsaw, IN; REF DNPALS. The...

Name: Z-0981-2009 DePuy DNP Anatomic Fracture Repair System, Locking Screw DNP Anatomic, Depuy, Warsaw, IN; REF DNPALS. The...
Creator: Depuy Orthopaedics, Inc.
Published: 2008-12-23
License: https://open.fda.gov/license/

Depuy Orthopaedics Inc. / initiated 2008-12-23 / Terminated / root cause: design

FDA source

Depuy Orthopaedics, Inc. began a recall of DePuy DNP Anatomic Fracture Repair System, Locking Screw DNP Anatomic, Depuy, Warsaw, IN; REF DNPALS. The device is used in the treatment of fractures and... on 2008-12-23. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0981-2009
Status: Terminated
Initiated: 2008-12-23
Posted: 2009-02-11
Terminated: 2010-10-18
Recalling firm: Depuy Orthopaedics Inc.
Product: DePuy DNP Anatomic Fracture Repair System, Locking Screw DNP Anatomic, Depuy, Warsaw, IN; REF DNPALS. The device is used in the treatment of fractures and osteotomies of the distal radius.
Product code: HRS Plate, Fixation, Bone
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.
Root cause tag: design
FDA 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 in commerce: Approx. 3,250 of all products
Distribution: Nationwide Distribution.
Product codes and lots: All lots.

Product code HRS

K052248Class IIDorsal Nail Plate, AnatomicalHand Innovations, LLC / cleared 2005-09-14

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)