Z-0927-06

Product is Optetrak Cemented Finned Tibial Tray Sz. 4F/5T. Knee prosthesis. Product is labeled in part...

Name: Z-0927-06 Product is Optetrak Cemented Finned Tibial Tray Sz. 4F/5T. Knee prosthesis. Product is labeled in part...
Creator: Exactech, Inc.
Published: 2005-12-19
License: https://open.fda.gov/license/

Exactech, Inc. / initiated 2005-12-19 / Terminated / root cause: packaging

FDA source

Exactech, Inc. began a recall of 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... on 2005-12-19. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0927-06
Status: Terminated
Initiated: 2005-12-19
Posted: 2006-06-02
Terminated: 2012-06-29
Recalling firm: Exactech, Inc.
Product: 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***. ''
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: 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 tag: packaging
FDA 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 in commerce: 14 implants from manufactured lot
Distribution: Distributed domestically to Alabama and Louisiana, and internationally to Spain, Germany and Greece.
Product codes and lots: Catalogue number 200-04-45; Serial number range 0730621-07306351; Lot number 452500.

Product code JWH

K932776Class IICruciate Retaining Cemented Tibial ComponentsExactech, Inc. / cleared 1994-10-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)