Z-1379-05

The product is a Finned Tibial Tray. Product is labeled in part: ''OPTETRAK FINNED TIBIAL TRAY A/P 53 mm ML...

Name: Z-1379-05 The product is a Finned Tibial Tray. Product is labeled in part: ''OPTETRAK FINNED TIBIAL TRAY A/P 53 mm ML...
Creator: Exactech, Inc.
Published: 2005-06-02
License: https://open.fda.gov/license/

Exactech, Inc. / initiated 2005-06-02 / Terminated / root cause: manufacturing process

FDA source

Exactech, Inc. began a recall of The product is a Finned Tibial Tray. Product is labeled in part: ''OPTETRAK FINNED TIBIAL TRAY A/P 53 mm ML 83mm***4F/5T Ti Alloy FITS ONLY SZ. 4 FEMORAL... on 2005-06-02. The reason FDA records is "Implant was identified incorrectly at the time of manufacture and then laser etched with the incorrect size information". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1379-05
Status: Terminated
Initiated: 2005-06-02
Posted: 2005-08-18
Terminated: 2008-10-24
Recalling firm: Exactech, Inc.
Product: The product is a Finned Tibial Tray. Product is labeled in part: ''OPTETRAK FINNED TIBIAL TRAY A/P 53 mm ML 83mm***4F/5T Ti Alloy FITS ONLY SZ. 4 FEMORAL CEMENTED***STERILE, SINGLE USE ONLY. FOR CEMENTED USE ONLY***''.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Implant was identified incorrectly at the time of manufacture and then laser etched with the incorrect size information.
Root cause tag: manufacturing process
FDA root cause: Other
Action: All consignees were notified by letter on 06/02/2005.
Quantity in commerce: 41
Distribution: Distributed to 15 Domestic Consignees 4 Foreign Distributors.
Product codes and lots: Serial number range 0696020 - 0696061.

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)