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FDAFDA · Alimentos y medicamentos·N.º oficial Z-0399-2019

StageOne Hip, Models 431207 & 431209Usage: Product Usage: The single-use cement spacer molds are sterile disposables made of medical grade silicone with a 316L stainless steel reinforcement stem. They are designed to be filled with polymethylmethacrylate/gentamicin bone cement, or equivalent, by injecting with a dispenser/gun into the mold. After the cement cures, the temporary spacers are to be removed from the molds with the reinforcement remaining as the core of the spacer, and placed into the joint space. The spacers remain in place (180 days or less) until the second stage of the two-stage procedure is performed to implant a conventional hip joint prosthesis.

Publicado el 14 de noviembre de 2018 · Inicio del retiro: 21 de septiembre de 2018

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

There is a potential for comingling of the 43MM and 51 MM molds

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Zimmer Biomet, Inc.
Distribuidor
US Nationwide Distribution in the states of: AZ, FL, MI, OH, VA & WI
Lote
Item Number 431207 Lot # 705550, UDI - (01)00880304447165(17)270927(10)705550 Item Number 431209 Lot # 705570, UDI - (01)00880304447141(17)270916(10)705570 Lot # 705580, UDI - (01)00880304447141(17)270916(10)705580
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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