Z-1011-04

3DKnee System, Stemmed Tibia-Nonporous-3D, Size 6, Right, sterile. Manufactured by Encore Orthopeadics, 9800...

Name: Z-1011-04 3DKnee System, Stemmed Tibia-Nonporous-3D, Size 6, Right, sterile. Manufactured by Encore Orthopeadics, 9800...
Creator: Encore Medical, LP
Published: 2004-05-10
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2004-05-10 / Terminated / root cause: labeling and UDI

FDA source

Encore Medical, LP began a recall of 3DKnee System, Stemmed Tibia-Nonporous-3D, Size 6, Right, sterile. Manufactured by Encore Orthopeadics, 9800 Metric Blvd., Austin, Texas 78758 on 2004-05-10. The reason FDA records is "Labeling is switched for the two products recalled. 3DKNEE is labeled as Foundation and Foundation is labeled as 3DKNEE". 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-1011-04
Status: Terminated
Initiated: 2004-05-10
Posted: 2004-07-20
Terminated: 2004-08-09
Recalling firm: Encore Medical, LP
Product: 3DKnee System, Stemmed Tibia-Nonporous-3D, Size 6, Right, sterile. Manufactured by Encore Orthopeadics, 9800 Metric Blvd., Austin, Texas 78758
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Labeling is switched for the two products recalled. 3DKNEE is labeled as Foundation and Foundation is labeled as 3DKNEE
Root cause tag: labeling and UDI
FDA root cause: Other
Action: The firm sent recall letters to all consignees on May 10, 2004 requesting return of the product.
Quantity in commerce: 16
Distribution: Product was distributed domesically to the following states: IA, MA, OK, TX, FL, CA, and SD. Product was shipped to one distributor in Germany.
Product codes and lots: Catalog number 333-02-106; Lot numbers 991141 and 991131

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)