Z-1255-2010

Foundation Knee System, Patella Trial, 26 mm, part number 802-01-019, Lot number 53944551

Name: Z-1255-2010 Foundation Knee System, Patella Trial, 26 mm, part number 802-01-019, Lot number 53944551
Creator: Encore Medical, Lp
Published: 2010-02-22
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2010-02-22 / Terminated / root cause: manufacturing process

FDA source

Encore Medical, Lp began a recall of Foundation Knee System, Patella Trial, 26 mm, part number 802-01-019, Lot number 53944551 on 2010-02-22. The reason FDA records is "One lot of product was incorrectly manufactured. Pegs are larger than specification". 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-1255-2010
Status: Terminated
Initiated: 2010-02-22
Posted: 2010-04-07
Terminated: 2010-07-22
Recalling firm: Encore Medical, LP
Product: Foundation Knee System, Patella Trial, 26 mm, part number 802-01-019, Lot number 53944551
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: One lot of product was incorrectly manufactured. Pegs are larger than specification.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Firm notified consignees by e-mail on 2/22/2010.
Quantity in commerce: 2 units
Distribution: United States (FL and ID).
Product codes and lots: Part Number 802-01-019 Lot 53944551

Product code JWH

K932246Class IIFoundation Metal-Backed PatellaEncore 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)