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U.S. Department of Health and Human Services

Class 2 Device Recall Depuy

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  Class 2 Device Recall Depuy see related information
Date Initiated by Firm September 14, 2006
Date Posted October 21, 2006
Recall Status1 Terminated 3 on April 26, 2007
Recall Number Z-0057-2007
Recall Event ID 36348
510(K)Number K961685  
Product Classification Patella - Product Code JWH
Product Depuy PFC Oval Dome Patella (Part Number 960100)3-Peg, 32 mm, sterile; REF 96-0100.
Code Information Lot 2203528.
Recalling Firm/
Depuy Orthopaedics, Inc.
700 Orthopaedic Dr
Warsaw IN 46582-3994
For Additional Information Contact
Manufacturer Reason
for Recall
Mislabeled: units containing a size 32 mm. patella were labeled as a 38 mm patella.
FDA Determined
Cause 2
Action The firm called their sales staff on 9/14/06 and instructed them to place a hold on the product, which entails pulling products from their own inventory and at any hospitals where it has been placed on consignment. Sales staff immediately visited hospital accounts and switched out the recalled lot for other product.
Quantity in Commerce 9
Distribution Nationwide.
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 = JWH and Original Applicant = JOHNSON & JOHNSON PROFESSIONALS, INC.