Device Recall ACCUPASS; ENDOSCRUB; Spectrum

  • 모델명 / 제조번호(시리얼번호)
    123263, 122504, 122406, 122592, 122482, 123043, 122289, 122518, 122511.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution.
  • 제품 설명
    - ACCU-PASS Suture Shuttle, 70 Degree, Upbend, (Orange) Ref. 72200419 Lot 122504 || - Carpal Tunnel Release Blade Assembly, (White) Ref. 81010 Lot 123263, 122406, 122482, 123043, 122518, 122511 || - ENDO-SCRUB 2, (1) Sheath, 0 Degree, For K. Storz, Medtronic Sharpsite AC, (Green) 4.0mm Ref. 19-12000 Lot 122289 || - Spectrum II Disposable Suture Hook 45 degree, Right (RED) Ref. C6380 Lot 122592 || Orthopedic manual surgical instrument.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Surgical Instrument Service And Savings, Inc., 2747 Sw 6th St, Redmond OR 97756-7109
  • 제조사 모회사 (2017)
  • Source
    USFDA