Recall Z-0439-2012
Endotec, Inc. · initiated September 21, 2011
Product
"***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 3-3X7.5 CAT 04-63-2133; SIZE 3-4X7.5 CAT 04-63-2134; SIZE 3-5X7.5 CAT 04-63-2135; SIZE 3-6X7.5 CAT 04-63-2136. Tricompartmental Knee Replacement
Codes / lots: LOT #'S 04632133ANN172, 04632134BNN249, 04632135BNN249, 04632136ANN172.
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: PMA
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.
Details
- Recall number
- Z-0439-2012
- Initiated
- September 21, 2011
- Posted by FDA
- January 11, 2012
- Terminated
- September 27, 2013
- Product code
- NRA – Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing
- Quantity
- 68
- Distribution
- USA (nationwide) including the states of AZ, CA, CT, FL, NE, NJ, OH, and OK.
- Recalling firm
- Endotec, Inc., Orlando, FL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0431-2012 | "***BUECHEL-PAPPAS Conforming Bearing***UHMWPE***SIZE***CAT**STERILE***ENDOTEC***Endotec…On 09/21/2011 Endotec, Orlando, FL initiated a recall for the Beuchel-Pappas Mobile Bearing Knee System (BP… | 09/21/2011Terminated |
| Z-0432-2012 | "***BUECHEL-PAPPAS Conforming Bearing***UHMWPE***SIZE***CAT**STERILE***ENDOTEC***Endotec…On 09/21/2011 Endotec, Orlando, FL initiated a recall for the Beuchel-Pappas Mobile Bearing Knee System (BP… | 09/21/2011Terminated |
| Z-0433-2012 | "***BUECHEL-PAPPAS Conforming Bearing***UHMWPE***SIZE***CAT**STERILE***ENDOTEC***Endotec…On 09/21/2011 Endotec, Orlando, FL initiated a recall for the Beuchel-Pappas Mobile Bearing Knee System (BP… | 09/21/2011Terminated |
| Z-0434-2012 | "***BUECHEL-PAPPAS Conforming Bearing***UHMWPE***SIZE***CAT**STERILE***ENDOTEC***Endotec…On 09/21/2011 Endotec, Orlando, FL initiated a recall for the Beuchel-Pappas Mobile Bearing Knee System (BP… | 09/21/2011Terminated |
| Z-0435-2012 | "***BUECHEL-PAPPAS Conforming Bearing***UHMWPE***SIZE***CAT**STERILE***ENDOTEC***Endotec…On 09/21/2011 Endotec, Orlando, FL initiated a recall for the Beuchel-Pappas Mobile Bearing Knee System (BP… | 09/21/2011Terminated |
| Z-0436-2012 | "***BUECHEL-PAPPAS CRUCIATE SACRIFICING BEARING ***MATERIAL UHMWPe***STERILE…On 09/21/2011 Endotec, Orlando, FL initiated a recall for the Beuchel-Pappas Mobile Bearing Knee System (BP… | 09/21/2011Terminated |
| Z-0437-2012 | "***BUECHEL-PAPPAS CRUCIATE SACRIFICING BEARING ***MATERIAL UHMWPe***STERILE…On 09/21/2011 Endotec, Orlando, FL initiated a recall for the Beuchel-Pappas Mobile Bearing Knee System (BP… | 09/21/2011Terminated |
| Z-0438-2012 | "***BUECHEL-PAPPAS CRUCIATE SACRIFICING BEARING ***MATERIAL UHMWPe***STERILE…On 09/21/2011 Endotec, Orlando, FL initiated a recall for the Beuchel-Pappas Mobile Bearing Knee System (BP… | 09/21/2011Terminated |
| Z-0440-2012 | "***BUECHEL-PAPPAS MODULAR TIBIAL BEARING ***MATERIAL UHMWPe***STERILE…On 09/21/2011 Endotec, Orlando, FL initiated a recall for the Beuchel-Pappas Mobile Bearing Knee System (BP… | 09/21/2011Terminated |
| Z-0441-2012 | "***BUECHEL-PAPPAS MODULAR TIBIAL BEARING ***MATERIAL UHMWPe***STERILE…On 09/21/2011 Endotec, Orlando, FL initiated a recall for the Beuchel-Pappas Mobile Bearing Knee System (BP… | 09/21/2011Terminated |
| Z-0442-2012 | "***BUECHEL-PAPPAS MODULAR TIBIAL BEARING ***MATERIAL UHMWPe***STERILE…On 09/21/2011 Endotec, Orlando, FL initiated a recall for the Beuchel-Pappas Mobile Bearing Knee System (BP… | 09/21/2011Terminated |
| Z-0443-2012 | "***BUECHEL-PAPPAS MODULAR TIBIAL BEARING ***MATERIAL UHMWPe***STERILE…On 09/21/2011 Endotec, Orlando, FL initiated a recall for the Beuchel-Pappas Mobile Bearing Knee System (BP… | 09/21/2011Terminated |