Z-0622-2010

Foundation Tibia Baseplate, Catalog number 324-01-108. The tibial is modular in design, such that plastic...

Name: Z-0622-2010 Foundation Tibia Baseplate, Catalog number 324-01-108. The tibial is modular in design, such that plastic...
Creator: Encore Medical, Lp
Published: 2009-12-03
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2009-12-03 / Terminated

FDA source

Encore Medical, Lp began a recall of Foundation Tibia Baseplate, Catalog number 324-01-108. The tibial is modular in design, such that plastic inserts of various thicknesses and intramedullary... on 2009-12-03. The reason FDA records is "Product does not meet specifications for a size 8 Right Foundation Tibia Baseplate". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0622-2010
Status: Terminated
Initiated: 2009-12-03
Posted: 2010-01-13
Terminated: 2010-05-05
Recalling firm: Encore Medical, LP
Product: Foundation Tibia Baseplate, Catalog number 324-01-108. The tibial is modular in design, such that plastic inserts of various thicknesses and intramedullary stem are attached to the metal baseplate intraoperatively.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Product does not meet specifications for a size 8 Right Foundation Tibia Baseplate.
FDA root cause: Mixed-up of materials/components
Action: Firm notified consignees by an Urgent Field Safety Notice dated 12/3/2009. The letter identified the product, stated the problem, and the risk associated with the problem. Customers are to immediately return the affected product and notify all of their customers if product was further distributed. Customers are to complete and return the enclosed response form. Questions should be directed to David Harris, Manager of Customer Service at 512-834-6330 or Valerie Moulton, International Customer Service at 512-834-6275.
Quantity in commerce: 17
Distribution: Worldwide Distribution -- USA, including states of GA, OK, FL, CA, and SD, and countries of Germany and Turkey.
Product codes and lots: Lot number 53986069

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)