Z-0196-2007

Optetrak, B-series cemented finned tibial tray size 2f/2t. Catalog # 220-04-02

Name: Z-0196-2007 Optetrak, B-series cemented finned tibial tray size 2f/2t. Catalog # 220-04-02
Creator: Exactech, Inc.
Published: 2006-08-31
License: https://open.fda.gov/license/

Exactech, Inc. / initiated 2006-08-31 / Terminated

FDA source

Exactech, Inc. began a recall of Optetrak, B-series cemented finned tibial tray size 2f/2t. Catalog # 220-04-02 on 2006-08-31. The reason FDA records is "Improperly machined parts: The Cemented Finned Tibial Trays could not seat the size 2 mating trial or polyethylene insert". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0196-2007
Status: Terminated
Initiated: 2006-08-31
Posted: 2006-11-21
Terminated: 2012-05-03
Recalling firm: Exactech, Inc.
Product: Optetrak, B-series cemented finned tibial tray size 2f/2t. Catalog # 220-04-02
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Improperly machined parts: The Cemented Finned Tibial Trays could not seat the size 2 mating trial or polyethylene insert.
FDA 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 in commerce: 30
Distribution: International distribution only---- including countries of South America, Africa and Europe
Product codes and lots: Serial numbers 0886395-0886424

Product code JWH

K010434Class IIOptetrak B-Series Total Knee SystemExactech, Inc. / cleared 2001-03-13

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)