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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 Systemsee related information
Date Initiated by FirmSeptember 21, 2011
Date PostedJanuary 11, 2012
Recall Status1 Terminated 3 on September 27, 2013
Recall NumberZ-0435-2012
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 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
Code Information K04330041A1NN467 K04330041A2NN741 K04330042A1NN467 K04330042A2NN467 K04330042A3NN741 K04330043A1NN467 K04330043A2NN467 K04330043A3NN741 K04330044A1NN467 K04330044A2NN741 K04330045A1NN742 K04330046A1NN742 
Recalling Firm/
Manufacturer		 Endotec, Inc.
300 Sunport Ln Ste 500
Orlando FL 32809-8123
For Additional Information ContactFaranak 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
ActionEndotec 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 Commerce146
DistributionUSA (nationwide) including the states of AZ, CA, CT, FL, NE, NJ, OH, and OK.
Total Product Life CycleTPLC 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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