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U.S. Department of Health and Human Services

Class 2 Device Recall Beuchal Pappas Mobile Bearing Knee System

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  Class 2 Device Recall Beuchal Pappas Mobile Bearing Knee System see related information
Date Initiated by Firm September 21, 2011
Date Posted January 11, 2012
Recall Status1 Terminated 3 on September 27, 2013
Recall Number Z-0443-2012
Recall Event ID 60138
Product Classification Prothesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing - Product Code NRA
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
Code Information LOT #'s:  04331032ANN286,  04331033ANN286,  04331034ANN286,  04331035ANN286,  04331036ANN286.
Recalling Firm/
Manufacturer		 Endotec, Inc.
300 Sunport Ln Ste 500
Orlando FL 32809-8123
For Additional Information Contact Faranak Gomarooni
800-323-9890
Manufacturer 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 Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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