Z-0826-2010

Encore Medical Foundation Knee Revision Baseplate, Part Number 321-01-106, Size 6, Left

Name: Z-0826-2010 Encore Medical Foundation Knee Revision Baseplate, Part Number 321-01-106, Size 6, Left
Creator: Encore Medical, Lp
Published: 2009-12-11
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2009-12-11 / Terminated / root cause: manufacturing process

FDA source

Encore Medical, Lp began a recall of Encore Medical Foundation Knee Revision Baseplate, Part Number 321-01-106, Size 6, Left on 2009-12-11. The reason FDA records is "Partial lot of product was not manufactured to specification. Central locking screw was missing threads. There is a potential for dissociation because the screw is not able to be used as a secondary fixation method". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0826-2010
Status: Terminated
Initiated: 2009-12-11
Posted: 2010-02-24
Terminated: 2010-09-24
Recalling firm: Encore Medical, LP
Product: Encore Medical Foundation Knee Revision Baseplate, Part Number 321-01-106, Size 6, Left
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Partial lot of product was not manufactured to specification. Central locking screw was missing threads. There is a potential for dissociation because the screw is not able to be used as a secondary fixation method.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Firm notified consignees by letter on 12/11/2009. The letter informs physicians that patients with implanted devices should counseled about the issue and should report any changes to their treating physician.
Quantity in commerce: 17
Distribution: TX, FL, GA, CA, AZ, Japan
Product codes and lots: Lot 53944312

Product code JWH

K932425Class IIFoundation Modular Tibial BaseplateEncore Orthopedics, Inc. / cleared 1994-07-22

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)