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U.S. Department of Health and Human Services

Class 2 Device Recall DePuy ASR 300 Acetabular Implant, 44 mm

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 Class 2 Recall
DePuy ASR 300 Acetabular Implant, 44 mm
see related information
Date Posted July 17, 2010
Recall Status1 Terminated on May 10, 2012
Recall Number Z-2046-2010
Recall Event ID 55575
Premarket Notification
510(K) Numbers
K040627  K073413  K080991 
Product Classification Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) - Product Code KWA
Product DePuy ASR 300 Acetabular Implant, 44 mm, 999830744, sterile, DePuy International, Ltd, Leeds, United Kingdom.
Code Information 2695187, 2695188, 2699904, 2699905, 2699906, 2706373, 2717802, 2717803, 2726896, 2746973, 2750584, 2786885 and 2787583,
Recalling Firm/
Manufacturer
Depuy Orthopaedics, Inc.
700 Orthopaedic Dr
Warsaw, Indiana 46582-3994
Manufacturer Reason
for Recall
Notification to clinicians of new revision rate data/information regarding the use of the device. As part of the post-market surveillance, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports. As part of the post-m
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
Action DePuy Orthopaedics issued a Field Safety Notice to share the new data with surgeons and to reiterate the importance of correct implant positioning and patient selection in achieving optimal implant performance and survivorshop. For additional information regarding this matter, please contact the DePuy Scientific Information Office at 888 554 2482.
Quantity in Commerce 46
Distribution Nationwide
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 = KWA and Original Applicant = DEPUY ORTHOPAEDICS, INC.
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