FDA Medical Device Recalls (openFDA)
Depuy Orthopaedics, Inc.: 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.
- Recall number
- Z-0981-2009
- 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.
- Status
- Terminated
- Initiated
- 2008-12-23
- Posted
- 2009-02-11
- Terminated
- 2010-10-18
- 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.
- Lot, serial or model codes
- All lots.
- 510(k) numbers
- ["K052248"]
- PMA numbers
- not on file
- Product code
- HRS
- Firm FEI
- 1818910
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28