Z-0443-2012

"BUECHEL-PAPPAS MODULAR TIBIAL BEARING MATERIAL UHMWPeSTERILE EOENDOTEC***Endotec, Inc. 20 Valley...

Name: Z-0443-2012 "***BUECHEL-PAPPAS MODULAR TIBIAL BEARING ***MATERIAL UHMWPe***STERILE EO***ENDOTEC***Endotec, Inc. 20 Valley...
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 MODULAR TIBIAL BEARING ***MATERIAL UHMWPe***STERILE EO***ENDOTEC***Endotec, Inc. 20 Valley Street South Orange NJ, 07079 USA Tel... 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-0443-2012
Status: Terminated
Initiated: 2011-09-21
Posted: 2012-01-11
Terminated: 2013-09-27
Recalling firm: Endotec, Inc.
Product: "***BUECHEL-PAPPAS MODULAR TIBIAL BEARING ***MATERIAL UHMWPe***STERILE EO***ENDOTEC***Endotec, Inc. 20 Valley Street South Orange NJ, 07079 USA Tel (973)762-6100***Wright Cremascoli Ortho Ltd. Unit 17 Goldworth Park Trading Estate Woking, Surrey GU213BA England Tel (0)1483-721404***" Size: 04-33-1032 Modular Tibial Bearing 2 X 7.5 04-33-1033 Modular Tibial Bearing 3 X 7.5 04-33-1034 Modular Tibial Bearing 4 X 7.5 04-33-1035 Modular Tibial Bearing 5 X 7.5 04-33-1036 Modular Tibial Bearing 6 X 7.5. 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: 31
Distribution: USA (nationwide) including the states of AZ, CA, CT, FL, NE, NJ, OH, and OK.
Product codes and lots: LOT #'s: 04331032ANN286, 04331033ANN286, 04331034ANN286, 04331035ANN286, 04331036ANN286.

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)