Z-0431-2012

"BUECHEL-PAPPAS Conforming BearingUHMWPESIZECATSTERILE*ENDOTEC***Endotec, Inc. 300 Sunport...

Name: Z-0431-2012 "***BUECHEL-PAPPAS Conforming Bearing***UHMWPE***SIZE***CAT**STERILE***ENDOTEC***Endotec, Inc. 300 Sunport...
Creator: Endotec, Inc.
Published: 2011-09-21
License: https://open.fda.gov/license/

Endotec, Inc. / initiated 2011-09-21 / Terminated

FDA source

Endotec, Inc. began a recall of "***BUECHEL-PAPPAS Conforming Bearing***UHMWPE***SIZE***CAT**STERILE***ENDOTEC***Endotec, Inc. 300 Sunport Lane, Suite 500 Orlando, FL 32809 USA***" SIZE 1 x... on 2011-09-21. The reason FDA records is "On 09/21/2011 Endotec, Orlando, FL initiated a recall for the Beuchel-Pappas Mobile Bearing Knee System (BP Knee). The BP Mobile Bearing Knee System consists of unapproved mobile (rotating) bearing tibial and patellar...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0431-2012
Status: Terminated
Initiated: 2011-09-21
Posted: 2012-01-11
Terminated: 2013-09-27
Recalling firm: Endotec, Inc.
Product: "***BUECHEL-PAPPAS Conforming Bearing***UHMWPE***SIZE***CAT**STERILE***ENDOTEC***Endotec, Inc. 300 Sunport Lane, Suite 500 Orlando, FL 32809 USA***" SIZE 1 x 0mm CAT 04-33-0001; SIZE 2 x 0mm CAT 04-33-0002; SIZE 3 x 0mm CAT 04-33-0003; SIZE 4 x 0mm CAT 04-33-0004; SIZE 5 x 0mm CAT 04-33-0005; SIZE 6 x 0mm CAT 04-33-0006. Tricompartmental Knee Replacement
Product code: NRA Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing
Reason for recall: On 09/21/2011 Endotec, Orlando, FL initiated a recall for the Beuchel-Pappas Mobile Bearing Knee System (BP Knee). The BP Mobile Bearing Knee System consists of unapproved mobile (rotating) bearing tibial and patellar components.
FDA root cause: PMA
Action: Endotec sent an "URGENT: MEDICAL DEVICE RECALL" letter dated September 21, 2011 to all affected customers. The letter described the product, problem, and actions to be taken by the customers. The letter instructs customers to examine and quarantine product subject to the recall. Additionally, a Response Form was included with the letter for customers to complete and return to the firm. Call 862-703-6730 for questions regarding this recall.
Quantity in commerce: 730
Distribution: USA (nationwide) including the states of AZ, CA, CT, FL, NE, NJ, OH, and OK.
Product codes and lots: 04330001Z001NN435 04330001Z005NN436 K04330002A1NN459 K04330002A2NN712 04330003ONN700 04330004NNN462 K04330004B1NN702 04330005Z001NN435 04330005NNN459 K04330005AANN733 04330005AANN736 04330005ABNN751 04330006Z001NN437 04330006H1NN749

Product code NRA

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)