Z-0347-05

Cemented Trapezoid Tibial Tray Sz. 4F/4T, Knee joint patellofemorotibial polymer/metal/polymer...

Name: Z-0347-05 Cemented Trapezoid Tibial Tray Sz. 4F/4T, Knee joint patellofemorotibial polymer/metal/polymer...
Creator: Exactech, Inc.
Published: 2004-11-11
License: https://open.fda.gov/license/

Exactech, Inc. / initiated 2004-11-11 / Terminated / root cause: labeling and UDI

FDA source

Exactech, Inc. began a recall of Cemented Trapezoid Tibial Tray Sz. 4F/4T, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis on 2004-11-11. The reason FDA records is "Implant was identified incorrectly at the time of manufacture and was then labeled and distributed with the incorrect size information". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0347-05
Status: Terminated
Initiated: 2004-11-11
Posted: 2004-12-23
Terminated: 2012-05-03
Recalling firm: Exactech, Inc.
Product: Cemented Trapezoid Tibial Tray Sz. 4F/4T, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
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 was then labeled and distributed with the incorrect size information.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: A recall letter was sent to all customers on November, 2, 2004 recalling all 21 units. These implants will be quarantined and then returned to the supplier for disposal when all 21 implants are received.
Quantity in commerce: 21 implants
Distribution: Distributed to New Jersey, Florida, Minnesota, New York, Maryland, Texas and the United Kingdom
Product codes and lots: Serial numbers 0638851-0638871

Product code JWH

K933610Class IIExactech Cemented Total Knee System, Tibial ComponentsExactech, Inc. / cleared 1995-01-17

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)