Device Recall ULTRAPOWER DIAMOND WHEEL Burs

  • Modèle / numéro de série
    All lots manufactured from July 01, 2004 and April 31, 2008.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution
  • Description du dispositif
    ST ULTRAPOWER DIAMOND WHEEL (RED) 25.4mm, Catalog Number 00702109200, STERILE, Single-use. Made is USA. || ST ULTRAPOWER Diamond Wheel/MDS M-51, (MUSTARD) 25.4 mm For Use with Low or Medium Speed Drills Only, Catalog Number 00702129200, STERILE. Made in USA. || ST ULTRAPOWER Diamond Wheel/MDS AM-51, (LIME) 25.4mm For Use with Low or Medium Speed Drills Only, Catalog Number 00702139200, STERILE. Made in USA. || ST ULTRAPOWER BUR Diamond Wheel/MDS TU-51 (TEAL) 25.4mm For Use with Low or Medium Speed Drills Only, Catalog Number 00702149200, STERILE. Made is USA. || Single use devices. || CONMED LINVATEC || 11311 Concept Blvd || Largo, FL 33773-4908 || Surgical instrument motors and accessories are AC-powered, or air-powered devices intended for the use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, a chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver and saw blade.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Linvatec Corp. dba ConMed Linvatec, 11311 Concept Blvd, Largo FL 33773-4908
  • Société-mère du fabricant (2017)
  • Source
    USFDA