Z-0522-2007

Polyethylene tibial posterior stabilized components. Optetrak All Poly Tibial PS Component. Knee prosthesis...

Name: Z-0522-2007 Polyethylene tibial posterior stabilized components. Optetrak All Poly Tibial PS Component. Knee prosthesis...
Creator: Exactech, Inc.
Published: 2006-12-07
License: https://open.fda.gov/license/

Exactech, Inc. / initiated 2006-12-07 / Terminated / root cause: manufacturing process

FDA source

Exactech, Inc. began a recall of Polyethylene tibial posterior stabilized components. Optetrak All Poly Tibial PS Component. Knee prosthesis. Catalog number : 204-11-13 on 2006-12-07. The reason FDA records is "The outside profile on this manufactured lot of devices is oversized and does not meet specifications". 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-0522-2007
Status: Terminated
Initiated: 2006-12-07
Posted: 2007-02-27
Terminated: 2012-07-11
Recalling firm: Exactech, Inc.
Product: Polyethylene tibial posterior stabilized components. Optetrak All Poly Tibial PS Component. Knee prosthesis. Catalog number : 204-11-13
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: The outside profile on this manufactured lot of devices is oversized and does not meet specifications.
Root cause tag: manufacturing process
FDA root cause: Other
Action: Letter dated 12/08/06. The firm representative retrieved all four devices from the field.
Quantity in commerce: 4 units
Distribution: Distributed to one hospital in New York.
Product codes and lots: serial numbers: 0900529-0900532

Product code JWH

K933494Class IIExactech Posterior Stabilized Cemented Total Knee SystemExactech, Inc. / cleared 1995-03-10

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)