Device Recall Rotating Tibial Platform ATTUNE INTUITION Impactor

  • Modèle / numéro de série
    CATALOG NO. : ATTUNE INTUITION Impactors  Rotating Tibial Platform, (254401004)  Barcode GTIN Number:  Rotating Tibial Platform, ......... 10603295130208  ALL LOTS
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) including P.R. except AK and RI; and Internationally to: Chile, Canada, Australia, Austria, Belgium, China, France, Ireland, India, Israel, Italy, Japan, Malaysia, Netherlands, New Zealand, Singapore, Slovakia, South Africa, South Korea, Spain, Switzerland, Thailand, United Arab Emirates (UAE), and United Kingdom (UK).
  • Description du dispositif
    Rotating Tibial Platform ATTUNE INTUITION Impactor. || The ATTUNE INTUITION Impactors are re-useable instruments utilized in knee replacement procedures. The three affected impactors are used at various times within the surgical flow, each impactor is used to impact and drive home its relevant mating part: Fixed Tibial bearing, (254401003) Rotating Tibial Platform, (254401004) and Femoral impactor, (254401006).
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    DePuy Orthopaedics, Inc., 700 Orthopaedic Dr, Warsaw IN 46582-3994
  • Société-mère du fabricant (2017)
  • Source
    USFDA