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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-0432-2012
Recall Event ID 60138
Product Classification Prothesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing - Product Code NRA
Product "***BUECHEL-PAPPAS Conforming Bearing***UHMWPE***SIZE***CAT**STERILE***ENDOTEC***Endotec, Inc. 300 Sunport Lane, Suite 500 Orlando, FL 32809 USA***"

SIZE 1 x 2.5mm CAT 04-33-0011;
SIZE 2 x 2.5mm CAT 04-33-0012;
SIZE 3 x 2.5mm CAT 04-33-0013;
SIZE 4 x 2.5mm CAT 04-33-0014;
SIZE 5 x 2.5mm CAT 04-33-0015;
SIZE 6 x 2.5mm CAT 04-33-0016.

Tricompartmental Knee Replacement
Code Information 04330011Z001NN436 K04330012A1NN712 K04330012A3NN720 04330012Z002NN443 K04330013A3NN720 K04330013A5NN750 04330014A1NN462 K04330014A1NN726 K04330014A2NN750 04330015Z005NN436 04330015Z001NN726 K04330015Z001-1NN453 04330015AANN752 04330016HNN749 
Recalling Firm/
Endotec, Inc.
300 Sunport Ln Ste 500
Orlando FL 32809-8123
For Additional Information Contact Faranak Gomarooni
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
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 452
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.