Recall Z-0347-05 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Exactech, Inc.
Cemented Trapezoid Tibial Tray Sz. 4F/4T, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
| Date | Dec 23, 2004 (initiated Nov 11, 2004) |
| Status | Terminated |
| Reason | Implant was identified incorrectly at the time of manufacture and was then labeled and distributed with the incorrect size information. |
| Root cause | Other |
| Action | A recall letter was sent to all customers on November, 2, 2004 recalling all 21 units. These implants will be quarantined and then returned to the supplier for disposal when all 21 implants are received. |
| Quantity | 21 implants |
| Distribution | Distributed to New Jersey, Florida, Minnesota, New York, Maryland, Texas and the United Kingdom |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K933610 | EXACTECH CEMENTED TOTAL KNEE SYSTEM, TIBIAL COMPONENTS Exactech, Inc., Jan 17, 1995 |