Device Recall MicroFuse Bone Void Filler

  • 모델명 / 제조번호(시리얼번호)
    Part number 838.202S (2.5cc), with lot # GBN299BB and expiration date October 2013, and lot #GBN355AB, with expiration date December 2013: and part # 838.210S (10cc) with lot # GBN319AB, with expiration date November 2013, and GBN320BB with expiration date November 2013.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    USA Nationwide Distribution.
  • 제품 설명
    Globus Medical MicroFuse Putty, 2.5cc and 10cc. || Product Usage: || MicroFuse Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. MicroFuse Bone Void Filleris a bone graft extender to be used with autogenous bone marrow aspirate or autograft
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Globus Medical, Inc., 2560 General Armistead Ave, Audubon PA 19403-5214
  • 제조사 모회사 (2017)
  • Source
    USFDA