Z-0332-06

Size 8 right 3DKnee Non-porous Baseplates (Catalog #333-02-108) joint knee replacement

Name: Z-0332-06 Size 8 right 3DKnee Non-porous Baseplates (Catalog #333-02-108) joint knee replacement
Creator: Encore Medical, Lp
Published: 2005-11-03
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2005-11-03 / Terminated / root cause: labeling and UDI

FDA source

Encore Medical, Lp began a recall of Size 8 right 3DKnee Non-porous Baseplates (Catalog #333-02-108) joint knee replacement on 2005-11-03. The reason FDA records is "The product is mislabeled in that Size 6 right Foundation may contain size 8 right 3D knee non-porous baseplates and vice versa. Device is intended to aid surgeon in relieving knee pain and restoring knee joint function". 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-0332-06
Status: Terminated
Initiated: 2005-11-03
Posted: 2005-12-29
Terminated: 2008-04-04
Recalling firm: Encore Medical, LP
Product: Size 8 right 3DKnee Non-porous Baseplates (Catalog #333-02-108) joint knee replacement.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: The product is mislabeled in that Size 6 right Foundation may contain size 8 right 3D knee non-porous baseplates and vice versa. Device is intended to aid surgeon in relieving knee pain and restoring knee joint function.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Firm initiated recall on 11/03/05 via letter to all consignees.
Quantity in commerce: 14 units.
Distribution: Device distributed to direct accounts in AZ, CA, FL, GA, MO, NJ, OK, SC, SD and TX. Foreign consignies located in Freiburg and Langelsheim, Germany.
Product codes and lots: Lot #434322.

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)