FDAFDA · Alimentos y medicamentos·N.º oficial Z-0286-2013
Special Orthopaedic Solution Peri-Acetabular Prosthesis V40 Femoral Extension Component Product Usage: The PAR extension piece is a component of the PAR assembly. The Peri-Acetabular Reconstruction (PAR) endoprosthesis was developed to meet the unique needs of patients who require reconstruction of large acetabular defects after a Type I and II pelvic resection.
Publicado el 21 de noviembre de 2012 · Inicio del retiro: 16 de julio de 2012
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
Stryker has become aware that insufficient taper torsional strength may result when a PAR extension piece is used with a forged CoCr stem.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Stryker Howmedica Osteonics Corp.
- Distribuidor
- Worldwide Distribution - US Nationwide
- Lote
- Multiple codes C-2051-7-004 RX00138D FEMORAL PELVIC EXTENSION C-2052-5-004 RX00146D FEMORAL PELVIC EXTENSION C-HM42-7-802 RX4278C 40MM EXT W/FEMALE V40 TAPER C-HM42-7-803 RX4278D 50MM EXT W/FEMALE V40 TAPER C-HM42-7-804 RX4278E 60MM EXT W/FEMALE V40 TAPER C-HM49-4-401 RX4944B PAR 40MM EXT W/FEMALE V40 TAPE C-HM49-4-402 RX4944C PAR 50MM EXT W/FEMALE V40 TAPE C-HM49-4-403 RX4944D PAR 60MM EXT W/FEMALE V40 TAPE C-HM49-9-202 RX4992C PAR EXTENSION C-TAPER 40MM C-HM49-9-203 RX4992D PAR EXTENSION C-TAPER 50MM C-HM49-9-204 RX4992E PAR EXTENSION C-TAPER 60MM C-HM52-1-802 RX5218C PAR FEMORAL EXT V40 TAPER 40MM C-KM10-9-400 HG102AA FEMORAL PELVIC EXTENSION C-KM26-5-204 RX2652E PAR FEM EXT V-40, 40MM C-KM26-5-205 RX2652S PAR FEM EXT V-40 50MM C-KM26-5-206 RX2652T PAR FEM EXT V-40 60MM C-KM28-1-501 RX2815B PAR FEM EXT V-40, 40MM C-KM28-1-502 RX2815C PAR FEM EXT V-40 50MM C-KM28-1-503 RX2815D PAR FEM EXT V-40 60MM C-KM28-4-201 RX2842B PAR FEM EXT V-40, 40MM C-KM28-4-202 RX2842C PAR FEM EXT V-40, 50MM C-KM28-4-203 RX2842D PAR FEM EXT V-40, 60MM C-KM28-6-901 RX2869B PAR FEM EXT V-40, 40MM C-KM28-6-902 RX2869C PAR FEM EXT V-40, 50MM C-KM28-6-903 RX2869D PAR FEM EXT V-40, 60MM C-KM28-7-801 RX2878B PAR FEM EXT V-40, 40MM C-KM28-7-802 RX2878C PAR FEM EXT V-40 50MM C-KM28-7-803 RX2878D PAR FEM EXT V-40 60MM C-KM29-6-101 KM2961B PAR FEM EXT V-40, 50MM C-KM29-6-102 RX2961C PAR FEM EXT V-40, 60MM C-KM29-9-101 RX2991B PAR FEM EXT V-40, 50MM C-KM29-9-102 RX2991C PAR FEM EXT V-40 60MM C-KM30-0-901 RX3009B PAR FEM EXT V-40, 50MM C-KM30-0-902 RX3009C PAR FEM EXT V-40, 60MM C-KM30-1-101 RX3011B PAR FEM EXT V-40, 50MM C-KM30-1-102 RX3011C PAR FEM EXT V-40 60MM C-KM32-0-801 RX3208B PAR FEM EXT V-40, 50MM C-KM32-0-802 RX3208C PAR FEM EXT V-40 60MM C-KM32-9-201 RX3292B 40MM EXT W/FEMALE V40 TAPER C-KM32-9-202 RX3292C 50MM EXT W/FEMALE V40 TAPER C-KM32-9-203 RX3292D 60MM EXT W/FEMALE V40 TAPER C-KM33-6-601 RX3366B 40MM EXT W/FEMALE V40 TAPER C-KM33-6-602 RX3366C 50MM EXT W/FEMALE V40 TAPER C-KM33-6-603 RX3366D 60MM EXT W/FEMALE V40 TAPER C-KM34-8-902 RX3489C 40MM EXT W/FEMALE V40 TAPER C-KM35-4-501 RX3545B 40MM EXT W/FEMALE V40 TAPER C-KM35-4-502 RX3545C 50MM EXT W/FEMALE V40 TAPER C-KM35-4-503 RX3545D 60MM EXT W/FEMALE V40 TAPER C-KM35-5-501 RX3555B 40MM EXT W/FEMALE V40 TAPER C-KM35-5-502 RX3555C 50MM EXT W/FEMALE V40 TAPER C-KM35-5-503 RX3555D 60MM EXT W/FEMALE V40 TAPER C-KM35-9-001 RX3590B 40MM EXT W/FEMALE V40 TAPER C-KM37-5-101 RX3751B 40MM EXT W/FEMALE V40 TAPER C-KM37-5-102 RX3751C 50MM EXT W/FEMALE V40 TAPER C-KM37-5-103 RX3751D 60MM EXT W/FEMALE V40 TAPER C-KM37-7-100 RX3771A 40MM EXT W/FEMALE V40 TAPER C-KM37-7-101 RX3771B 50MM EXT W/FEMALE V40 TAPER C-KM37-7-102 RX3771C 60MM EXT W/FEMALE V40 TAPER C-KM37-7-801 RX3778B 40MM EXT W/FEMALE V40 TAPER C-KM37-7-803 RX3778D 60MM EXT W/FEMALE V40 TAPER C-KM37-8-401 RX3784B 40MM EXT W/FEMALE V40 TAPER C-KM37-8-402 RX3784C 60MM EXT W/FEMALE V40 TAPER C-KM38-1-301 RX3813B 40MM EXT W/FEMALE V40 TAPER C-KM38-1-302 RX3813C 50MM EXT W/FEMALE V40 TAPER C-KM38-1-303 RX3813D 60MM EXT W/FEMALE V40 TAPER C-KM39-1-101 RX3911B 40MM EXT W/FEMALE V40 TAPER C-KM39-1-102 RX3911C 50MM EXT W/FEMALE V40 TAPER C-KM39-1-103 RX3911D 60MM EXT W/FEMALE V40 TAPER C-KM40-1-301 RX4013B 40MM EXT W/FEMALE V40 TAPER C-KM40-1-302 RX4013C 50MM EXT W/FEMALE V40 TAPER C-KM40-1-303 RX4013D 60MM EXT W/FEMALE V40 TAPER C-KM40-6-400 RX4064A 40MM EXT W/FEMALE V40 TAPER C-KM40-7-301 RX4073B 40MM EXT W/FEMALE V40 TAPER C-KM40-7-302 RX4073C 50MM EXT W/FEMALE V40 TAPER C-KM40-9-501 RX4095B 40MM EXT W/FEMALE V40 TAPER C-KM40-9-502 RX4095C 50MM EXT W/FEMALE V40 TAPER C-KM40-9-503 RX4095D 60MM EXT W/FEMALE V40 TAPER C-KM41-3-001 RX4130B 40MM EXT W/FEMALE V40 TAPER C-KM41-3-002 RX4130C 50MM EXT W/FEMALE V40 TAPER C-KM41-3-003 RX4130D 60MM EXT W/FEMALE V40 TAPER C-KM41-6-401 RX4164B 40MM EXT W/FEMALE V40 TAPER C-KM41-6-402 RX4164C 50MM EXT W/FEMALE V40 TAPER C-KM41-
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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