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U.S. Department of Health and Human Services

Class 3 Device Recall DYNASTY ACLASS POLY LINER

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 Class 3 Recall
DYNASTY ACLASS POLY LINER
see related information
Date Posted August 12, 2010
Recall Status1 Terminated on May 31, 2011
Recall Number Z-2212-2010
Recall Event ID 56131
Premarket Notification
510(K) Number
K082924 
Product Classification Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) - Product Code JDL
Product DYNASTY® A-CLASS® POLY LINER, REF DLXP-LD36, 1 EACH, Rx ONLY, STERILE EO, GROUP D, I.D. 36 mm, LIP 15o, LINER STD, Wright Medical Technology, 4677 Airline Road, Arlington, TN 38002. Product is used in total hip arthroplasty.
Code Information Lot number: 0501136375
Recalling Firm/
Manufacturer
Wright Medical Technology Inc
5677 Airline Rd
Arlington, Tennessee 38002
For Additional Information Contact Debbie Daurer
901-387-9971
Manufacturer Reason
for Recall
The inner and outer product packaging was missing the following information: shelf life, translations, manufacturing date, CE marking and also listed the incorrect sterilization method.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Error in Labeling
Action On 06/28/2010, Wright Medical Technology sent a letter to consignees. Consignees were instructed to examine their inventory for recalled product and return it to the firm. Consignees should contact customer service at 800-238-7117 for return instructions and replacement inventory. Questions concerning the recall should be directed to Debby Daurer at 800-874-5630.
Quantity in Commerce 6 units
Distribution USA distirbution only, in states of WI, WV, IN, IA, and GA
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 = JDL and Original Applicant = WRIGHT MEDICAL TECHNOLOGY, INC.
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