Z-0435-2012

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

Name: Z-0435-2012 "***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-0435-2012
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 10mm CAT 04-33-0041; SIZE 2 x 10mm CAT 04-33-0042; SIZE 3 x 10mm CAT 04-33-0043; SIZE 4 x 10mm CAT 04-33-0044; SIZE 5 x 10mm CAT 04-33-0045; SIZE 6 x 10mm CAT 04-33-0046. 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: 146
Distribution: USA (nationwide) including the states of AZ, CA, CT, FL, NE, NJ, OH, and OK.
Product codes and lots: K04330041A1NN467 K04330041A2NN741 K04330042A1NN467 K04330042A2NN467 K04330042A3NN741 K04330043A1NN467 K04330043A2NN467 K04330043A3NN741 K04330044A1NN467 K04330044A2NN741 K04330045A1NN742 K04330046A1NN742

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)