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U.S. Department of Health and Human Services

Class 2 Device Recall DePuy ASR 100 Acetabular Implant 44mm

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  Class 2 Device Recall DePuy ASR 100 Acetabular Implant 44mm see related information
Date Initiated by Firm March 05, 2010
Date Posted July 17, 2010
Recall Status1 Terminated 3 on May 10, 2012
Recall Number Z-2031-2010
Recall Event ID 55575
510(K)Number K080991  
Product Classification Prosthesis, hip, semi-constrained (metal uncemented acetabular component) - Product Code KWA
Product DePuy ASR 100 Acetabular Implant, 44 mm, 999800744, sterile, DePuy International, Ltd, Leeds, United Kingdom.
Code Information 1935006, 1958057, 1958058, 1958059, 1958060, 1958061, 1958062, 1960337, 1960338, 1960339, 1960340, 1960341, 1960342, 2094451, 2094452, 2094469, 2140480, 2140481, 2140482, 2140483, 2155841, 2155842, 2155843, 2155844, 2156082, 2156083, 2172335, 2172336, 2172337, 2172338, 2172339, 2178246, 2178247, 2178248, 2178249, 2178251, 2179277, 2179278, 2179279, 2179282, 2205782, 2205783, 2205784, 2205785, 2205786, 2324941, 2459084, 2467248, 2467249, 2591200, 2609946, 2609947 and Y28HV1000.
Recalling Firm/
Manufacturer		 Depuy Orthopaedics, Inc.
700 Orthopaedic Dr
Warsaw IN 46582-3994
For Additional Information Contact
574-267-8143
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joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports.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
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 388
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 = KWA and Original Applicant = DEPUY ORTHOPAEDICS, INC.
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