Recall Z-0438-2012 ยท NRA Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing
Endotec, Inc.
"***BUECHEL-PAPPAS CRUCIATE SACRIFICING BEARING ***MATERIAL UHMWPe***STERILE EO***ENDOTEC***Endotec, Inc. 300 Sunport Lane, Suite 500 Orlando, FL 32809 USA***CAT.NO.***SIZE***" SIZE 3-3X5 CAT 04-63-2123; SIZE 3-4X5 CAT 04-63-2124; SIZE 3-5X5 CAT 04-63-2125; SIZE 3-6X5 CAT 04-63-2126. Tricompartmental Knee Replacement
| Date | Jan 11, 2012 (initiated Sep 21, 2011) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 60 |
| Distribution | USA (nationwide) including the states of AZ, CA, CT, FL, NE, NJ, OH, and OK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.