3.2mm Drill Bit. This is a component within the PediLoc Locking Plate System utilized to pre-drill a hole in bone prior to placement of a bone screw.
Publicado el 21 de agosto de 2013 · Inicio del retiro: 24 de julio 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
OrthoPediatrics has initiated a voluntary recall of Part # 01-1050-002, 2.5mm Drill Bit, Lot #91300335. Only drill bits that are in their original packaging are being recalled. The description on the package of this drill bit has a wrong size in the description (3.2mm). The recall affects only packaged devices still in original packaging due to misbranding of the product. The drill bit itself has
Qué hacer
Voluntary: Firm initiated · Telephone
Detalles del retiro
- Fabricante
- OrthoPediatrics Corp
- Distribuidor
- Nationwide distribution, including the states of MO, MI, WA, FL, NY, TN, CO, AZ, VA, TX, CA, MN, LA, NC, and UT.
- Lote
- LOT 91300335 - Catalogue Number 01-1050-0002
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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