Endotec, Inc.
South Orange, NJ, US
Endotec, Inc. appears in FDA device records in South Orange, NJ. FDA records list 15 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 20 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 15 510(k) clearances for Endotec, Inc. between 1991 and 2009. The busiest year on record is 1991, with 3. The most recent is 2009, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1991 | 3 |
| 1993 | 1 |
| 1994 | 2 |
| 1995 | 1 |
| 1996 | 2 |
| 1997 | 2 |
| 1999 | 2 |
| 2002 | 1 |
| 2009 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K081400 | FANNING-PAPPAS MODULAR KNEE BEARING | JWH | Substantially Equivalent | |
| K012702 | BUECHEL-PAPPAS (B-P) FIXED BEARING NEW JERSEY (NJ) TOTAL KNEE, MODEL 1 | JWH | Substantially Equivalent | |
| K992394 | BUECHEL-PAPPAS HUMERAL HEAD RESURFACING COMPONENT | HSD | Substantially Equivalent | |
| K982418 | BUECHEL-PAPPAS MODULAR SALVAGE STEM | MJT | Substantially Equivalent | |
| K963101 | B-P HEMISPHERICAL ACETABULAR COMPONENT | LPH | Substantially Equivalent | |
| K963100 | TRONZO ACETABULAR FIXATION COMPONENT (1 99-02-00XX (ACE. FIXATION CUP) XX=OD OF ACE. CUP | LPH | Substantially Equivalent | |
| K960425 | BUECHEL-PAPPAS POLYETHLENE ACETABULAR COMPONENT(01-42-YYXX & 01-43-YYXX | JDI | Substantially Equivalent | |
| K960424 | BUECHEL-PAPPAS POLYETHYLENE GLENOID COMPONENT (02-11-YYXX) NOTE:YY=ID & XX=OD | KWT | Substantially Equivalent | |
| K945254 | ELECTROSURGICAL CUTTING & COAGULATION DEVICE ACCESSORIES | GEI | Substantially Equivalent | |
| K944465 | CARRIER, LIGATURE (79 GEJ) | GCJ | Substantially Equivalent | |
| K944414 | DEKALB | GCJ | Substantially Equivalent | |
| K905262 | BUECHEL-PAPPAS EXTENDED COLLAR FEMORAL STEM PROSTH | JDI | Substantially Equivalent for Some Indications | |
| K904870 | MODIFIED NEW JERSEY FEMORAL HIP RESURFACING COMPON | KXA | Substantially Equivalent | |
| K904880 | BUECHEL-PAPPAS HUMERAL STEM COMPONENT | KWS | Substantially Equivalent | |
| K904879 | BEUCHEL-PAPPAS GLENOID COMPONENT | KWS | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- GCJLaparoscope, General & Plastic Surgery
- KXAProsthesis, Hip, Femoral, Resurfacing
- JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
- MJTProsthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, Cemented Or Uncemented
- KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
- KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0443-2012 | "***BUECHEL-PAPPAS MODULAR TIBIAL BEARING ***MATERIAL UHMWPe***STERILE EO***ENDOTEC***Endotec, Inc. 20 Valley Street South Orange NJ, 07079 USA Tel (973)762-6100***Wright Cremascoli Ortho Ltd. Unit 17 Goldworth Park Trading Estate Woking, Surrey GU213BA England Tel (0)1483-721404***" Size: 04-33-1032 Modular Tibial Bearing 2 X 7.5 04-33-1033 Modular Tibial Bearing 3 X 7.5 04-33-1034 Modular Tibial Bearing 4 X 7.5 04-33-1035 Modular Tibial Bearing 5 X 7.5 04-33-1036 Modular Tibial Bearing 6 X 7.5. Tricompartmental Knee Replacement | 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. | Terminated | ||
| Z-0442-2012 | "***BUECHEL-PAPPAS MODULAR TIBIAL BEARING ***MATERIAL UHMWPe***STERILE EO***ENDOTEC***Endotec, Inc. 20 Valley Street South Orange NJ, 07079 USA Tel (973)762-6100***Wright Cremascoli Ortho Ltd. Unit 17 Goldworth Park Trading Estate Woking, Surrey GU213BA England Tel (0)1483-721404***" Size: 04-33-1022 Modular Tibial Bearing 2 x 5 04-33-1023 Modular Tibial Bearing 3 X 5 04-33-1024 Modular Tibial Bearing 4 X 5 04-33-1025 Modular Tibial Bearing 5 X 5 04-33-1026 Modular Tibial Bearing 6 X 5. Tricompartmental Knee Replacement | 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. | Terminated | ||
| Z-0441-2012 | "***BUECHEL-PAPPAS MODULAR TIBIAL BEARING ***MATERIAL UHMWPe***STERILE EO***ENDOTEC***Endotec, Inc. 20 Valley Street South Orange NJ, 07079 USA Tel (973)762-6100***Wright Cremascoli Ortho Ltd. Unit 17 Goldworth Park Trading Estate Woking, Surrey GU213BA England Tel (0)1483-721404***" Size: 04-33-1012 Modular Tibial Bearing 2 X 2.5 04-33-1013 Modular Tibial Bearing 3 X 2.5 04-33-1014 Modular Tibial Bearing 4 X 2.5 04-33-1015 Modular Tibial Bearing 5 X 2.5 04-33-1016 Modular Tibial Bearing 6 X 2.5. Tricompartmental Knee Replacement | 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. | Terminated | ||
| Z-0440-2012 | "***BUECHEL-PAPPAS MODULAR TIBIAL BEARING ***MATERIAL UHMWPe***STERILE EO***ENDOTEC***Endotec, Inc. 20 Valley Street South Orange NJ, 07079 USA Tel (973)762-6100***Wright Cremascoli Ortho Ltd. Unit 17 Goldworth Park Trading Estate Woking, Surrey GU213BA England Tel (0)1483-721404***" Cat #: 04-33-1002 Modular Tibial Bearing 2 X 0 Cat #: 04-33-1003 Modular Tibial Bearing 3 X 0 Cat #: 04-33-1004 Modular Tibial Bearing 4 X 0 Cat #: 04-33-1005 Modular Tibial Bearing 5 X 0 Cat #: 04-33-1006 Modular Tibial Bearing 6 X 0. Tricompartmental Knee Replacement | 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. | Terminated | ||
| Z-0439-2012 | "***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 | 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. | Terminated | ||
| Z-0438-2012 | "***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 | 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. | Terminated | ||
| Z-0437-2012 | "***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 3-3X2.5 CAT 04-63-2113; SIZE 3-4X2.5 CAT 04-63-2114; SIZE 3-5X2.5 CAT 04-63-2115; SIZE 3-6X2.5 CAT 04-63-2116. Tricompartmental Knee Replacement | 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. | Terminated | ||
| Z-0436-2012 | "***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 3-3X0 CAT 04-63-2103; SIZE 3-4X0 CAT 04-632104; SIZE 3-5X0 CAT 04-63-2105; SIZE 3-6X0 CAT 04-63-2106. Tricompartmental Knee Replacement | 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. | Terminated | ||
| Z-0435-2012 | "***BUECHEL-PAPPAS Conforming Bearing***UHMWPE***SIZE***CAT**STERILE***ENDOTEC***Endotec, Inc. 300 Sunport Lane, Suite 500 Orlando, FL 32809 USA***" SIZE 1 x 10mm CAT 04-33-0041; SIZE 2 x 10mm CAT 04-33-0042; SIZE 3 x 10mm CAT 04-33-0043; SIZE 4 x 10mm CAT 04-33-0044; SIZE 5 x 10mm CAT 04-33-0045; SIZE 6 x 10mm CAT 04-33-0046. Tricompartmental Knee Replacement | 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. | Terminated | ||
| Z-0434-2012 | "***BUECHEL-PAPPAS Conforming Bearing***UHMWPE***SIZE***CAT**STERILE***ENDOTEC***Endotec, Inc. 300 Sunport Lane, Suite 500 Orlando, FL 32809 USA***" SIZE 1 x 7.5mm CAT 04-33-0031; SIZE 2 x 7.5mm CAT 04-33-0032; SIZE 3 x 7.5mm CAT 04-33-0033; SIZE 4 x 7.5mm CAT 04-33-0034; SIZE 5 x 7.5mm CAT 04-33-0035; SIZE 6 x 7.5mm CAT 04-33-0036. Tricompartmental Knee Replacement | 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. | Terminated | ||
| Z-0433-2012 | "***BUECHEL-PAPPAS Conforming Bearing***UHMWPE***SIZE***CAT**STERILE***ENDOTEC***Endotec, Inc. 300 Sunport Lane, Suite 500 Orlando, FL 32809 USA***" SIZE 1 x 5mm CAT 04-33-0021; SIZE 2 x 5mm CAT 04-33-0022; SIZE 3 x 5mm CAT 04-33-0023; SIZE 4 x 5mm CAT 04-33-0024; SIZE 5 x 5mm CAT 04-33-0025; SIZE 6 x 5mm CAT 04-33-0026. Tricompartmental Knee Replacement | 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. | Terminated | ||
| Z-0432-2012 | "***BUECHEL-PAPPAS Conforming Bearing***UHMWPE***SIZE***CAT**STERILE***ENDOTEC***Endotec, Inc. 300 Sunport Lane, Suite 500 Orlando, FL 32809 USA***" SIZE 1 x 2.5mm CAT 04-33-0011; SIZE 2 x 2.5mm CAT 04-33-0012; SIZE 3 x 2.5mm CAT 04-33-0013; SIZE 4 x 2.5mm CAT 04-33-0014; SIZE 5 x 2.5mm CAT 04-33-0015; SIZE 6 x 2.5mm CAT 04-33-0016. Tricompartmental Knee Replacement | 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. | Terminated | ||
| Z-0431-2012 | "***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 | 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. | Terminated | ||
| Z-1627-2010 | Endotec Prothesis Ankle, Titanium Alloy, Sterilized, BP Ankle System. BP Ankle System, B-P Type II Talar Ankle Component: Size 1 B-P Type II Talar Ankle Component Catalog: 05-01-0101, Size 2 B-P Type II Talar Ankle Component Catalog: 05-01-0102, Size 3 B-P Type II Talar Ankle Component Catalog: 05-01-0103, Size 4 B-P Type II Talar Ankle Component Catalog: 05-01-0104, Size 5 B-P Type II Talar Ankle Component Catalog: 05-01-0105, Size 6 B-P Type II Talar Ankle Component Catalog: 05-01-0106. BP Ankle System, BP Type II Ankle Bearing: 3x5mm BP Type II Ankle Bearing Catalog: 05-02-0103, 3x6mm BP Type II Ankle Bearing Catalog: 05-02-0113, 3x7mm BP Type II Ankle Bearing Catalog: 05-02-0123, 3x9mm BP Type II Ankle Bearing Catalog: 05-02-0143, 3x11mm BP Type II Ankle Bearing Catalog: 05-02-0163, 3x13mm BP Type II Ankle Bearing Catalog: 05-02-0183, 4x5mm BP Type II Ankle Bearing Catalog: 05-02-0104, 4x6mm BP Type II Ankle Bearing Catalog: 05-02-0114, 4x7mm BP Type II Ankle Bearing Catalog:05-02-0124, 5x5mm BP Type II Ankle Bearing Catalog: 05-02-0105, 5x7mm BP Type II Ankle Bearing Catalog: 05-02-0125, 5x9mm BP Type II Ankle Bearing Catalog: 05-02-0145. 5x6mm BP Type II Ankle Bearing Catalog 05-02-0106. 6x5mm BP Type II Ankle Bearing Catalog 05-02-0115. 6x6mm BP Type II Ankle Bearing Catalog 05-02-0116. 7x6mm BP Type II Ankle Bearing Catalog 05-02-0126. 9x6mm BP Type II Ankle Bearing Catalog 05-02-0146. 11x5mm BP Type II Ankle Bearing Catalog 05-02-0165. 11x6mm BP Type II Ankle Bearing Catalog 05-02-0166. 13x5mm BP Type II Ankle Bearing Catalog 05-02-0185. 13x6mm BP Type II Ankle Bearing Catalog 05-02-0186. BP Ankle System, B-P Type II Tibial Ankle Component Size 1 B-P Type II Tibial ankle Component Catalog: 05-03-0101, Size 2 B-P Type II Tibial ankle Component Catalog: 05-03-0102, Size 3 B-P Type II Tibial ankle Component Catalog: 05-03-0103, Size 4 B-P Type II Tibial ankle Component Catalog: 05-03-0104, Size 5 B-P Type II Tibial ankle Component Catalog: 05-03-0105, Size 6 B-P Type II Tibial ankle Component Catalog: 05-03-0106. | Endotec is recalling B-P Hip, B-P Shoulder, and B-P Knee Replacement System devices due to sterility issues involving validation, process variations and test results. | Terminated | ||
| Z-1626-2010 | TMJ Components: Right Ramus Component - DelCristo Catalog: 09-11-0215, TMJ - Shah Catalog: 09-42-0217, 09-11-0217. Left Fossa Component - DelCristo Catalog 09-42-0216, Left Ramus Component - DelCristo Catalog: 09-11-0216. | Endotec is recalling B-P Hip, B-P Shoulder, and B-P Knee Replacement System devices due to sterility issues involving validation, process variations and test results. | Terminated | ||
| Z-1625-2010 | Endotec Prothesis Ankle, Titanium Alloy, Sterilized, BP Ankle System. BP Ankle System, F-P Type III Ankle Bearing Component: 2x5mm F-P Type III Ankle Bearing Catalog: 05-13-0532, 2x7mm F-P Type III Ankle Bearing Catalog: 05-13-0732, 8x3mm F-P Type III Ankle Bearing Catalog: 05-13-0533, 8x1mm F-P Type III Ankle Bearing Catalog: 05-13-0731. BP Ankle System, F-P Type III Tibial Ankle Component: Size 1 F-P Type III Tibial Component Catalog: 05-12-0031, Size 2 F-P Type III Tibial Component Catalog: 05-12-0032, Size 3 F-P Type III Tibial Component Catalog: 05-12-0033. BP Ankle System, F-P Type III Talar Component: Size 1 F-P Type III Talar Component Catalog: 05-01-0031, Size 2 F-P Type III Talar Component Catalog: 05-01-0032, Size 3 F-P Type III Talar Component Catalog: 05-01-0033. | Endotec is recalling B-P Hip, B-P Shoulder, and B-P Knee Replacement System devices due to sterility issues involving validation, process variations and test results. | Terminated | ||
| Z-1624-2010 | Endotec Prothesis Ankle, Titanium Alloy, Sterilized. BP Ankle System, Talar Ankle Component: Size 2 Talar Component Catalog: 05-01-0002, Size 3 Talar Component Catalog: 05-01-0003, Size 4 Talar Component Catalog: 05-01-0004, Size 5 Talar Component Catalog: 05-01-0005, BP Ankle System, Thick Talar Ankle Component: Size 2 Thick Talar Component Catalog: 05-11-0002, Size 3 Thick Talar Component Catalog: 05-11-0003, Size 5 Thick Talar Component Catalog: 05-11-0005, B-P Ankle System, Tibial Component: Size 2 Tibial Component 05-03-0002, Size 3 Tibial Component 05-03-0003, Size 4 Tibial Component 05-03-0004, Size 5 Tibial Component 05-03-0005, | Endotec is recalling B-P Hip, B-P Shoulder, and B-P Knee Replacement System devices due to sterility issues involving validation, process variations and test results. | Terminated | ||
| Z-1623-2010 | Endotec Prothesis Hip, Titanium Alloy, Sterilized. Acetabular Bearing, BP Hip System Component: 32x54 Acetabular Bearing, Catalog: 01-02-3254, 32x56 Acetabular Bearing, Catalog: 01-02-3256, Femoral Head Resurfacing Component, BP Hip System Component: 36.5mm Femoral Head Resurfacing Component:, Catalog: 01-03-0036, 38mm Femoral Head Resurfacing Component:, Catalog: 01-03-0038, 39.5mm Femoral Head Resurfacing Component:, Catalog: 01-03-0039, 41mm Femoral Head Resurfacing Component:, Catalog: 01-03-0041, 42.5mm Femoral Head Resurfacing Component:, Catalog: 01-03-0042, 44mm Femoral Head Resurfacing Component:, Catalog: 01-03-0044, 45.5mm Femoral Head Resurfacing Component:, Catalog: 01-03-0045, 47mm Femoral Head Resurfacing Component:, Catalog: 01-03-0047, 49mm Femoral Head Resurfacing Component:, Catalog: 01-03-0049, 51mm Femoral Head Resurfacing Component:, Catalog: 01-03-0051, 52mm Femoral Head Resurfacing Component:, Catalog: 01-03-0052. Femoral Stem BP Hip System Component: 10mm Femoral Stem Catalog: 01-04-0110, 11mm Femoral Stem Catalog: 01-04-0111, 12mm Femoral Stem Catalog: 01-04-0112. | Endotec is recalling B-P Hip, B-P Shoulder, and B-P Knee Replacement System devices due to sterility issues involving validation, process variations and test results. | Terminated | ||
| Z-1622-2010 | Endotec Prosthesis Shoulder, Titanium Alloy, Sterilized Modular Femoral Stem BP Shoulder Component: 12mm Modular Femoral Stem, Catalog: 02-21-0103, Lot 02-21-0103ANN374. | Endotec is recalling B-P Hip, B-P Shoulder, and B-P Knee Replacement System devices due to sterility issues involving validation, process variations and test results. | Terminated | ||
| Z-1621-2010 | Endotec, Prosthesis Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, Titanium Alloy, Sterilized, (Beuchel-Pappas (BP)) The B-P Knee Replacement System is composed of several components used to provide surgeons with different intra-operative options. All metallic components are available in six sizes and are fabricated from Ti-6Al-4V titanium alloy by Endotec. BP Knee Replacement System Component, Modular Femoral Component: Size 5 Left Modular Femoral Component, Catalog: 04-31-2105, Lot No. 04-31-2105A; Size 4 Left Modular Femoral Component, Lot No. 04-31-2104A, Size 6 Left Femoral Component, Lot No. 04-31-2106A1. BP Knee Replacement System Component, Narrow Femoral Component: Size 3 Right Narrow Femoral Component Lot No. 04-31-1303C, Size 3 Left Narrow Femoral Component Lot No. 04-31-2303C, Size 4 Right Narrow Femoral Component Lot No. 04-31-1304C, Size 4 Left Narrow Femoral Component Lot No. 04-31-2304C. BP Knee Replacement System Component, All Poly Patella: Size 1 All Poly Patella Lot No. 04-34-0201B, 04-34-0201C, 04-34-0201D, 04-34-0201E. Size 2 All Poly Patella Lot No. 04-34-0202B, 04-34-0202C, 04-34-0202D, 04-03-0202E. BP Knee Replacement System Component, 3 Peg Patella: Size 4 3-Peg Patella Lot No. 04-34-0004H. BP Knee Replacement System Component, Conforming Bearing: 1x0mm Conforming Bearing Catalog: 04-33-001, 1x2.5mm Conforming Bearing Catalog: 04-33-0011, 1x5mm Conforming Bearing Catalog: 04-33-0021, 1x7.5mm Conforming Bearing Catalog: 04-33-0031, 2x0mm Conforming Bearing Catalog: 04-33-0002, 2x2.5mm Conforming Bearing Catalog: 04-33-0012, 2x5mm Conforming Bearing Catalog: 04-33-0022, 2x7.5mm Conforming Bearing Catalog: 04-33-0032, 3x0mm Conforming Bearing Catalog: 04-33-0003, 3x2.5mm Conforming Bearing Catalog: 04-33-0013, 3x5mm Conforming Bearing Catalog: 04-33-0023, 3x7.5mm Conforming Bearing Catalog: 04-33-0033, 4x0mm Conforming Bearing Catalog: 04-33-0004, 4x2.5mm Conforming Bearing Catalog: 04-33-0014, 4x5mm Conforming Bearing Catalog: 04-33-0024, 4x7.5mm Conforming Bearing Catalog: 04-33-0034, 5x0mm Conforming Bearing Catalog: 04-33-0005, 5x2.5mm Conforming Bearing Catalog: 04-33-0015 5x5mm Conforming Bearing Catalog: 04-33-0025, 5x7.5mm Conforming Bearing Catalog: 04-33-0035, 6x0mm Conforming Bearing Catalog: 04-33-0006, 6x2.5mm Conforming Bearing Catalog: 04-33-0016, BP Knee Replacement System Component, Screw Stop: Size 4-6 Screw Stop Catalog: 03-12-0036. BP Knee Replacement System Component, Tibial Component Type 1 w/o Biocoat: Size 1 Type 1 Tibial Component w/o Biocoat Catalog: 04-32-0401, Size 2 Type 1 Tibial Component w/o Biocoat Catalog: 04-32-0402, Size 3 Type 1 Tibial Component w/o Biocoat Catalog: 04-32-0403, Size 4 Type 1 Tibial Component w/o Biocoat Catalog: 04-32-0404, Size 5 Type 1 Tibial Component w/o Biocoat Catalog: 04-32-0405, Size 6 Type 1 Tibial Component w/o Biocoat Catalog: 04-32-0406. BP Knee Replacement System Component, Tibial Component Type 1: Size 1 Type 1 Tibial Component Catalog: 04-32-0001, Size 3 Type 1 Tibial Component Catalog: 04-32-0003, Size 4 Type 1 Tibial Component Catalog: 04-32-0004. BP Knee Replacement System Component, Tibial Component Type 2: Size 3 Type 2 Tibial Component Catalog: 04-32-0013. BP Knee Replacement System Component, Tibial Component Type 0: Size 5 Type 0 Tibial Platform Catalog: 04-32-0065. BP Knee Replacement System Component, Femoral Component w/o Biocoat: Size 1 Right Femoral Component w/o Biocoat Catalog: 04-31-1201, Size 1 Left Femoral Component w/o Biocoat Catalog:04-31-2201, Size 2 Right Femoral Component w/o Biocoat Catalog: 04-31-1202, Size 2 Left Femoral Component w/o Biocoat Catalog:04-31-2202, Size 3 Right Femoral Component w/o Biocoat Catalog:04-31-1203, Size 3 Left Femoral Component w/o Biocoat Catalog:04-31-2203, Size 4 Right Femoral Component w/o Biocoat Catalog:04-31- | Endotec is recalling B-P Hip, B-P Shoulder, and B-P Knee Replacement System devices due to sterility issues involving validation, process variations and test results. | Terminated |
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