Device Recall APEX INTERFACE Hemi 54X and Flared 56X, 3 Hole Acetabular Shells

  • 모델명 / 제조번호(시리얼번호)
    H5-12354: Lots - 20127 and 20167; H5-11356: Lot - 20097
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US Nationwide Distribution in the states of IL, VA, CO, UT, NY, FL, MA, OK, CA, TN and WY.
  • 제품 설명
    APEX INTERFACE Hemi 54X and Flared 56X, 3 Hole Acetabular Shells; Model: H5-12354, H5-11356. || Product Usage: || The Apex Interface Acetabular System is intended for use in combination with the Apex Modular Hip Stem in total hip replacement procedures.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Omnilife Science Inc., 50 Oconnell Way Ste 10, East Taunton MA 02718-1394
  • 제조사 모회사 (2017)
  • Source
    USFDA