FDAFDA · Alimentos y medicamentos·N.º oficial Z-0896-2013
Firebird Spinal Fixation System, Parallel Rod Connector (52-6800) and Axial Rod Connector (52-6700). Product Usage: The connector assemblies allow for rod components to be connected side-to-side, or end-to-end and eliminate the need of rebuilding the entire system with a longer rod in order to include the new vertebral levels.
Publicado el 6 de marzo de 2013 · Inicio del retiro: 1 de febrero de 2013
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 possibility that the Set Screw (p/n 90-2923) sub-component of the Parallel Rod Connector Assembly (p/n 52-6800) & Axial Rod Connector (p/n 52-6700) may crack during final tightening. Orthofix Inc received six (6) customer complaints related to set screw cracking between November 15, 2010 and December 2012.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Orthofix, Inc
- Distribuidor
- Worldwidewide Distribution - USA Nationwide including Puerto Rico and the countries of: Australia, Lebanon, Germany, Spain, Sweden and Israel.
- Lote
- Catalog Numbers: 52-6800 & 52-6700; All Lot Numbers
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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