FDAFDA · Alimentos y medicamentos·N.º oficial Z-0276-2014
3.5MM LOCKING SCREW, T15 HEXALOBE, SELF TAPPING, 34MM The OrthoPediatrics Proximal Femur Plating System combines implants and instruments in one convenient system. This system offers the advantages of the osteotomy blade plates and cannulated instrumentation. Osteotomy plates provide ease of reduction and good rotational stability while maintaining bone stock. Cannulated instruments work over a guide wire for precise placement and safety. The subject device is a Bone Screw designed for use with this system.
Publicado el 20 de noviembre de 2013 · Inicio del retiro: 26 de septiembre 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
The firm identified, through complaints that the 3.5MM LOCKING SCREW packaging material was marked as a 3.5mm screw and the part number was correct but that the description indicated a 7.0mm screw. Upon investigation, it has been determined that a lot number 009U2 was packaged and mislabeled internally by OrthoPediatrics.
Qué hacer
Voluntary: Firm initiated · E-Mail
Detalles del retiro
- Fabricante
- OrthoPediatrics Corp
- Distribuidor
- Worldwide Distribution - US including Michigan and the countries of Ireland and Australia
- Lote
- Part Number:. 00-0903-2634 and lot number 009U2
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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