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U.S. Department of Health and Human Services

Class 2 Device Recall PolyAx Locking Plate System

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  Class 2 Device Recall PolyAx Locking Plate System see related information
Date Initiated by Firm November 01, 2010
Date Posted March 07, 2011
Recall Status1 Terminated 3 on June 27, 2012
Recall Number Z-1583-2011
Recall Event ID 57396
510(K)Number K060969  
Product Classification Bone Fixation Plate - Product Code HRS
Product PolyAx Locking Plate System, POLYAX FEMORAL PLATE - LEFT, 9 hole, Sterile, REF 8141-31-109, Depuy Orthopaedics, Inc., Warsaw, IN.
Code Information DLHCRC.
Recalling Firm/
Manufacturer		 Depuy Orthopaedics, Inc.
700 Orthopaedic Dr
Warsaw IN 46582-3994
For Additional Information Contact Katherine Seppa
574-267-8143
Manufacturer Reason
for Recall		 The firm determined that the 8.0 mm hole threads in the PolyAx Distal Femoral Locking Plate were incorrectly manufactured, which prevents the mating screw from locking in place. The screw should lock with the plate, instead the screw passes through the plate.
FDA Determined
Cause 2		 Other
Action Urgent Information - Recall Notice letters, dated November 1, 2010 were sent to customers. The letters described the reason for recall and identified the product affected along with the affected units. The letters also provided clinical guidance and stated that the problem had been corrected and that DePuy was in the process of replenishing its inventory. Hospitals were to determine if any of the recalled components they received were still on hand, and return them immediately to their DePuy Representative or directly to DePuy for credit.
Quantity in Commerce 246 all products
Distribution Nationwide Distribution -- ME, MA, FL, VA, CO, TX, WY, AZ, MO, WI, GA, PA, AL, NY, OH, NJ, NC, and CA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HRS and Original Applicant = DEPUY ORTHOPAEDICS, INC.
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