| Class 2 Device Recall Beuchal Pappas Mobile Bearing Knee System | |
Date Initiated by Firm | September 21, 2011 |
Date Posted | January 11, 2012 |
Recall Status1 |
Terminated 3 on September 27, 2013 |
Recall Number | Z-0431-2012 |
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 0mm CAT 04-33-0001;
SIZE 2 x 0mm CAT 04-33-0002;
SIZE 3 x 0mm CAT 04-33-0003;
SIZE 4 x 0mm CAT 04-33-0004;
SIZE 5 x 0mm CAT 04-33-0005;
SIZE 6 x 0mm CAT 04-33-0006.
Tricompartmental Knee Replacement |
Code Information |
04330001Z001NN435 04330001Z005NN436 K04330002A1NN459 K04330002A2NN712 04330003ONN700 04330004NNN462 K04330004B1NN702 04330005Z001NN435 04330005NNN459 K04330005AANN733 04330005AANN736 04330005ABNN751 04330006Z001NN437 04330006H1NN749 |
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 | 730 |
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.
|
|
|
|