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U.S. Department of Health and Human Services

Class 2 Device Recall DePuy DNP Anatomic Fracture Repair System

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 Class 2 Recall
DePuy DNP Anatomic Fracture Repair System
see related information
Date Posted February 11, 2009
Recall Status1 Terminated on October 18, 2010
Recall Number Z-0983-2009
Recall Event ID 50700
Premarket Notification
510(K) Number
K052248 
Product Classification Plate, Fixation, Bone - Product Code HRS
Product DePuy DNP Anatomic Fracture Repair System, DNP Anatomic Left, Depuy, Warsaw, IN; REF DNPAL. The device is used in the treatment of fractures and osteotomies of the distal radius.
Code Information All lots.
Recalling Firm/
Manufacturer
Depuy Orthopaedics, Inc.
700 Orthopaedic Dr
Warsaw, Indiana 46582-3994
Manufacturer 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.
FDA Determined
Cause 2
DESIGN: 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = HRS and Original Applicant = HAND INNOVATIONS, LLC.
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