Z-1433-2010

3DKNEE SYSTEM, 3D Knee Tibial Insert-DCM, Sterile, Right, size 4 x 11mm. Encore Medical, LP. Austin, TX...

Name: Z-1433-2010 3DKNEE SYSTEM, 3D Knee Tibial Insert-DCM, Sterile, Right, size 4 x 11mm. Encore Medical, LP. Austin, TX...
Creator: Encore Medical, Lp
Published: 2010-03-19
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2010-03-19 / Terminated / root cause: packaging

FDA source

Encore Medical, Lp began a recall of 3DKNEE SYSTEM, 3D Knee Tibial Insert-DCM, Sterile, Right, size 4 x 11mm. Encore Medical, LP. Austin, TX 78758-5445. Intended to aid the surgion in relieving... on 2010-03-19. The reason FDA records is "Affected product had incorrect color label which is a secondary visual indicator for sizing". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1433-2010
Status: Terminated
Initiated: 2010-03-19
Posted: 2010-04-26
Terminated: 2010-07-22
Recalling firm: Encore Medical, LP
Product: 3DKNEE SYSTEM, 3D Knee Tibial Insert-DCM, Sterile, Right, size 4 x 11mm. Encore Medical, LP. Austin, TX 78758-5445. Intended to aid the surgion in relieving the patient of knee pain and restoring knee joint function.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Affected product had incorrect color label which is a secondary visual indicator for sizing.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Encore Medical, LP notified consignees by e-mail dated March 19, 2010. Consignees were requested to return the affected product to the firm. For further information, contact Encore Medical, LP at 1-888-838-3668.
Quantity in commerce: 7 units
Distribution: Worldwide Distribution -- United States (UT, IA) and Germany.
Product codes and lots: Catalog Number: 392-11-604, Lot Number: 59600085.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)