Endotec, Inc.
Medical device manufacturer in Orlando, FL.
15510(k) clearances
0PMA approvals
20recalls
Device types
- KWS Prosthesis, Shoulder, Semi-Constrained… 2
- JDI Prosthesis, Hip, Semi-Constrained… 2
- GCJ Laparoscope, General & Plastic Surgery 2
- LPH Prosthesis, Hip, Semi-Constrained… 2
- JWH Prosthesis, Knee, Patellofemorotibial… 2
- KXA Prosthesis, Hip, Femoral, Resurfacing 1
- GEI Electrosurgical, Cutting & Coagulation &… 1
- KWT Prosthesis, Shoulder, Non-Constrained… 1
- MJT Prosthesis, Shoulder, Humeral (Bipolar… 1
- HSD Prosthesis, Shoulder, Hemi-, Humeral… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K081400 | Fanning-Pappas Modular Knee BearingJWH · Traditional | 02/20/2009SE |
| K012702 | Buechel-Pappas (B-P) Fixed Bearing New Jersey (NJ) Total Knee, Model 1JWH · Traditional | 01/30/2002SE |
| K992394 | Buechel-Pappas Humeral Head Resurfacing ComponentHSD · Traditional | 10/15/1999SE |
| K982418 | Buechel-Pappas Modular Salvage StemMJT · Abbreviated | 04/29/1999SE |
| K963101 | B-P Hemispherical Acetabular ComponentLPH · Traditional | 02/12/1997SE |
| K963100 | Tronzo Acetabular Fixation Component (1 99-02-00XX (Ace. Fixation Cup) Xx=Od of Ace. CupLPH · Traditional | 02/12/1997SE |
| K960425 | Buechel-Pappas Polyethlene Acetabular COMPONENT(01-42-YYXX & 01-43-YYXXJDI · Traditional | 10/03/1996SE |
| K960424 | Buechel-Pappas Polyethylene Glenoid Component (02-11-YYXX) Note:Yy=Id & Xx=OdKWT · Traditional | 08/26/1996SE |
| K945254 | Electrosurgical Cutting & Coagulation Device AccessoriesGEI · Traditional | 06/06/1995SE |
| K944465 | Carrier, Ligature (79 Gej)GCJ · Traditional | 09/28/1994SE |
| K944414 | DekalbGCJ · Traditional | 09/27/1994SE |
| K905262 | Buechel-Pappas Extended Collar Femoral Stem ProsthJDI · Traditional | 05/19/1993SN |
| K904870 | Modified New Jersey Femoral Hip Resurfacing ComponKXA · Traditional | 05/23/1991SE |
| K904880 | Buechel-Pappas Humeral Stem ComponentKWS · Traditional | 01/28/1991SE |
| K904879 | Beuchel-Pappas Glenoid ComponentKWS · Traditional | 01/28/1991SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| 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 |
| 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-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-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-0439-2012 | "***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-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-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-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-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-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-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-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-1627-2010 | Endotec Prothesis Ankle, Titanium Alloy, Sterilized, BP Ankle System. BP Ankle System…Endotec is recalling B-P Hip, B-P Shoulder, and B-P Knee Replacement System devices due to sterility issues… | 06/05/2009Terminated |
| Z-1626-2010 | TMJ Components: Right Ramus Component - DelCristo Catalog: 09-11-0215, TMJ - Shah…Endotec is recalling B-P Hip, B-P Shoulder, and B-P Knee Replacement System devices due to sterility issues… | 06/05/2009Terminated |
| Z-1625-2010 | Endotec Prothesis Ankle, Titanium Alloy, Sterilized, BP Ankle System. BP Ankle System…Endotec is recalling B-P Hip, B-P Shoulder, and B-P Knee Replacement System devices due to sterility issues… | 06/05/2009Terminated |
| Z-1624-2010 | Endotec Prothesis Ankle, Titanium Alloy, Sterilized. BP Ankle System, Talar Ankle…Endotec is recalling B-P Hip, B-P Shoulder, and B-P Knee Replacement System devices due to sterility issues… | 06/05/2009Terminated |
| Z-1623-2010 | Endotec Prothesis Hip, Titanium Alloy, Sterilized. Acetabular Bearing, BP Hip System…Endotec is recalling B-P Hip, B-P Shoulder, and B-P Knee Replacement System devices due to sterility issues… | 06/05/2009Terminated |
| Z-1622-2010 | Endotec Prosthesis Shoulder, Titanium Alloy, Sterilized Modular Femoral Stem BP Shoulder…Endotec is recalling B-P Hip, B-P Shoulder, and B-P Knee Replacement System devices due to sterility issues… | 06/05/2009Terminated |
| Z-1621-2010 | Endotec, Prosthesis Knee, Patellofemorotibial, Semi-Constrained, Cemented…Endotec is recalling B-P Hip, B-P Shoulder, and B-P Knee Replacement System devices due to sterility issues… | 06/05/2009Terminated |