—#92717

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.

FDA product code: JDL — Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
Device class: Class 3
Medical specialty: Orthopedic
510(k) numbers: K082924
Affected lot / code info: Lot number: 0501136375

Why it was recalled

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.

Root cause (FDA determination)

Software design (manufacturing process)

Action the firm took

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.

Recalling firm

Firm: Wright Medical Technology Inc
Address: 5677 Airline Rd, Arlington, Tennessee 38002

Distribution

Distribution pattern: USA distirbution only, in states of WI, WV, IN, IA, and GA

Timeline

Recall initiated: 2010-06-07
Posted by FDA: 2010-08-12
Terminated: 2011-05-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #92717. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.