Z-2244-2010

3DKnee Baseplates, Size 8, Left, Part # 333-01-108, Lot# A1000003

Name: Z-2244-2010 3DKnee Baseplates, Size 8, Left, Part # 333-01-108, Lot# A1000003
Creator: Encore Medical, Lp
Published: 2010-06-28
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2010-06-28 / Terminated / root cause: labeling and UDI

FDA source

Encore Medical, Lp began a recall of 3DKnee Baseplates, Size 8, Left, Part # 333-01-108, Lot# A1000003 on 2010-06-28. The reason FDA records is "One lot of product has an incorrect color label. The color label is a secondary visual indicator of sizing". 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-2244-2010
Status: Terminated
Initiated: 2010-06-28
Posted: 2010-08-22
Terminated: 2010-10-04
Recalling firm: Encore Medical, LP
Product: 3DKnee Baseplates, Size 8, Left, Part # 333-01-108, Lot# A1000003.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: One lot of product has an incorrect color label. The color label is a secondary visual indicator of sizing.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Firm notified their consignees by letter on June 28, 2010.
Quantity in commerce: 18
Distribution: Florida, Missouri, and Italy
Product codes and lots: Size 8, Left, Part # 333-01-108, Lot# A1000003

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)