Recall Z-2212-2010 ยท JDL Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
Wright Medical Technology Inc
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.
| Date | Aug 12, 2010 (initiated Jun 7, 2010) |
| Status | Terminated |
| Reason | 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 | 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 | 6 units |
| Distribution | USA distirbution only, in states of WI, WV, IN, IA, and GA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082924 | DYNASTY POROUS ACETABULAR SHELL, DYNASTY POLYETHYLENE ACETABULAR LINER, DYNASTY METAL ACETABULAR LINER Wrightmedicaltechnologyinc, Mar 6, 2009 |