Recall Z-1636-2010 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Wright Medical Technology Inc
ADVANCE DURAMER TIBIAL INSERT, REF: KIMP-312L, SIZE 3 LEFT MEDIAL PIVOT, THICKNESS 12MM, 1 EACH, STERILE EO, Wright Medical Technology, 4677 Airline Road, Arlington, TN 38002. Indicated for use in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients.
| Date | May 21, 2010 (initiated Nov 24, 2009) |
| Status | Terminated |
| Reason | The left medial pivot and right medial pivot inserts were co-mingled |
| Root cause | Packaging process control |
| Action | Wright Medical Technology, Inc. issued an "Urgent: Medical Device Voluntary Recall" notification dated November 24, 2009. The letters were addressed to distributors, hospital administrators, and surgeons. Consignees were asked to return all affected product in addition to a completed Response Form to the firm. For further information, contact Wright Medical Technology, Inc. at 1-800-874-5630. |
| Quantity | 23 units |
| Distribution | Worldwide Distribution -- United States, The Netherlands, Italy, Republic of Korea and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K972770 | ADVANCE ULTRA-CONGRUENT TIBIAL INSERT Wrightmedicaltechnologyinc, Oct 21, 1997 |