Recall Z-1716-2009 ยท JDL Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
Wright Medical Technology Inc
CONSERVE, TOTAL A-CLASS HEAD W/BFH TECH., REF 38AM-3635, O.D. Size: 36mm, Neck Length: +3.5mm, Taper: SLT, Sterile R, 1 each, Rx only, Wright Medical Technology, Inc., 5677 Airline, Road, Arlington, TN 38002. The CONSERVE Total Femoral Head is indicated for use in total hip arthroplasty for reduction of relief of pain and/or improved hip function in skeletally mature patients.
| Date | May 14, 2009 |
| Status | Terminated |
| Reason | Incorrect packaging, swapped sizes |
| Root cause | Packaging process control |
| Action | Wright Medical Technology, Inc. notified hospitals, surgeons and their distributors of the recall situation via an "Urgent: Medical Device Voluntary Recall" notice dated May 14, 2009 explaining the problem, the hazard involved and requesting confirmation that the product was removed from their inventory. The letter included a "Fax Back" response page to ensure the receipt of the notice. For further questions, contact Wright Medical Technologies, Inc. at 1-800-874-5630. |
| Quantity | 15 units |
| Distribution | Worldwide Distribution -- Including states of NC, TN, IA, IN, MD, WI, WV, OK, WA, PA, TN, TX, FL and CA and country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051348 | CONSERVE TOTAL FEMORAL HEAD Wrightmedicaltechnologyinc, Aug 19, 2005 |