CTL Medical Hex Driver, 1/4" Square QC, 4.0 Ratcheting Ref 015.7050
Publicado el 27 de marzo de 2019 · Inicio del retiro: 5 de julio 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
the anti-toggle ring of the hex driver may separate from the driver shaft. If this occurs during surgery, the anti-toggle ring can be pressed into the pedicle screw head and cause separation of the screw from the housing upon tightening. if the anti-toggle ring remains in the pedicle crew head and can interfere with final tightening of the pedicle screw construct. this can lead to failure of the set crew and relies of the rod from the construct.
Qué hacer
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Detalles del retiro
- Fabricante
- CTL Medical Corporation
- Distribuidor
- distributor and user level
- Lote
- Lot 7EQAB-D, 7ATAB-D
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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