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.
FDA Recall Z-2212-2010 · Posted 2010-08-12
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Recalling FirmWright Medical Technology Inc
Recall StatusTerminated
Product CodeJDL
Date Initiated2010-06-07
Date Terminated2011-05-31
Product Quantity6 units
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.
Firm 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.
Root Cause
Software design (manufacturing process)
Distribution Pattern
USA distirbution only, in states of WI, WV, IN, IA, and GA
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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