Z-1539-2008

3DKNEE Tibial Insert Trial, Size 2, 13mm Right; Part #801-01-640; manufactured by Encore Medical, L.P...

Name: Z-1539-2008 3DKNEE Tibial Insert Trial, Size 2, 13mm Right; Part #801-01-640; manufactured by Encore Medical, L.P...
Creator: Encore Medical, Lp
Published: 2008-02-20
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2008-02-20 / Terminated / root cause: labeling and UDI

FDA source

Encore Medical, Lp began a recall of 3DKNEE Tibial Insert Trial, Size 2, 13mm Right; Part #801-01-640; manufactured by Encore Medical, L.P., Austin, TX 78758. Used in surgery to determine the... on 2008-02-20. The reason FDA records is "Tibial insert trial incorrectly marked for thickness; device thickness marked correctly as 13mm on the underside of the trial, but is incorrectly marked as 15mm on the side". 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-1539-2008
Status: Terminated
Initiated: 2008-02-20
Posted: 2008-08-20
Terminated: 2008-09-02
Recalling firm: Encore Medical, LP
Product: 3DKNEE Tibial Insert Trial, Size 2, 13mm Right; Part #801-01-640; manufactured by Encore Medical, L.P., Austin, TX 78758. Used in surgery to determine the correct size of 3DKnee component to implant that would allow for the best range of motion and joint stability.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Tibial insert trial incorrectly marked for thickness; device thickness marked correctly as 13mm on the underside of the trial, but is incorrectly marked as 15mm on the side.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Firm notified consignee by phone and asked them to return any outstanding product on 02/20/08.
Quantity in commerce: 6 units.
Distribution: Distribution --- country of Germany.
Product codes and lots: Lot #53906407

Product code JWH

K020114Class II3D KneeEncore Orthopedics, Inc. / cleared 2002-07-12

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)