Terminated

"BUECHEL-PAPPAS MODULAR TIBIAL BEARING MATERIAL UHMWPeSTERILE EOENDOTECEndotec, Inc. 20 Valley Street South Orange NJ, 07079 USA Tel (973)762-6100Wright Cremascoli Ortho Ltd. Unit 17 Goldworth Park Trading Estate Woking, Surrey GU213BA England Tel (0)1483-721404***" Cat #: 04-33-1002 Modular Tibial Bearing 2 X 0 Cat #: 04-33-1003 Modular Tibial Bearing 3 X 0 Cat #: 04-33-1004 Modular Tibial Bearing 4 X 0 Cat #: 04-33-1005 Modular Tibial Bearing 5 X 0 Cat #: 04-33-1006 Modular Tibial Bearing 6 X 0. Tricompartmental Knee Replacement

FDA Recall Z-0440-2012 · Posted 2012-01-11

Recalling FirmEndotec, Inc.

Recall StatusTerminated

Product CodeNRA

Date Initiated2011-09-21

Date Terminated2013-09-27

Product Quantity39

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.

Firm 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.

Root Cause

PMA

Distribution Pattern

USA (nationwide) including the states of AZ, CA, CT, FL, NE, NJ, OH, and OK.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.