Device Recall Fixed Tibial bearing ATTUNE INTUITION Impactor

  • 모델명 / 제조번호(시리얼번호)
    CATALOG NO. : ATTUNE INTUITION Impactors  Fixed Tibial Bearing, (254401003)  Barcode GTIN Number:  Fixed Tibial Bearing, ......... 10603295130192   ALL LOTS
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    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).
  • 제품 설명
    Fixed Tibial bearing 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

제조사

  • 제조사 주소
    DePuy Orthopaedics, Inc., 700 Orthopaedic Dr, Warsaw IN 46582-3994
  • 제조사 모회사 (2017)
  • Source
    USFDA