"***BUECHEL-PAPPAS CRUCIATE SACRIFICING BEARING ***MATERIAL UHMWPe***STERILE EO***ENDOTEC***Endotec, Inc. 300 Sunport La
FDA device recall Z-0437-2012 · posted 2012-01-11 · Terminated
Recall details
- Recalling firm
- Endotec, Inc.
- 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.
- Action taken
- 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.
- Root cause
- PMA
- Status
- Terminated
- Product code
- NRA
- Quantity affected
- 55
- Distribution
- USA (nationwide) including the states of AZ, CA, CT, FL, NE, NJ, OH, and OK.
- Date initiated
- 2011-09-21
- Date posted
- 2012-01-11
- Date terminated
- 2013-09-27
- Location
- Orlando, FL
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