Recall Z-0196-2007 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Exactech, Inc.
Optetrak, B-series cemented finned tibial tray size 2f/2t. Catalog # 220-04-02
| Date | Nov 21, 2006 (initiated Aug 31, 2006) |
| Status | Terminated |
| Reason | Improperly machined parts: The Cemented Finned Tibial Trays could not seat the size 2 mating trial or polyethylene insert. |
| Root cause | Other |
| Action | The recall was initiated on August 31, 2006. The distributors were notified by FAX, email and telephone. The returned devices will be stored quarantine. |
| Quantity | 30 |
| Distribution | International distribution only---- including countries of South America, Africa and Europe |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010434 | OPTETRAK B-SERIES TOTAL KNEE SYSTEM Exactech, Inc., Mar 13, 2001 |