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Class 3 Device Recall DYNASTY ACLASS POLY LINER |
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Date Initiated by Firm |
June 07, 2010 |
Date Posted |
August 12, 2010 |
Recall Status1 |
Terminated 3 on May 31, 2011 |
Recall Number |
Z-2212-2010 |
Recall Event ID |
56131 |
510(K)Number |
K082924
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Product Classification |
Prothesis, hip, semi-contrained (metal cemented acetaular component) - Product Code JDL
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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 TN 38002
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For Additional Information Contact |
Debbie Daurer 901-387-9971
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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.
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FDA Determined Cause 2 |
Software design (manufacturing process) |
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
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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.
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510(K) Database |
510(K)s with Product Code = JDL and Original Applicant = WRIGHT MEDICAL TECHNOLOGY, INC.
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