Recall Z-0927-06 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Exactech, Inc.
Product is Optetrak Cemented Finned Tibial Tray Sz. 4F/5T. Knee prosthesis. Product is labeled in part: ''OPTETRAK FINNED TIBIAL TRAY A/P53 mm M/L 83mm***STERILE, SINGLE USE ONLY FOR CEMENTED USE ONLY***EXACTECH Gainesville, FL 32653***. ''
| Date | Jun 2, 2006 (initiated Dec 19, 2005) |
| Status | Terminated |
| Reason | An implant within a lot of finned tibial trays manufactured at Exactech was not made to specification. The locking cavity in the tibial tray was not fully machined thus preventing the tibial insert from locking in place. |
| Root cause | Other |
| Action | Each consignee contacted by mail 12/19/2005, and asked to return the product to Exactech. The returned product will be quarantined and evaluated. |
| Quantity | 14 implants from manufactured lot |
| Distribution | Distributed domestically to Alabama and Louisiana, and internationally to Spain, Germany and Greece. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K932776 | CRUCIATE RETAINING CEMENTED TIBIAL COMPONENTS Exactech, Inc., Oct 20, 1994 |