Device Recall Low Profile U Joint Driver for the SynFix Mini Open System

  • 모델명 / 제조번호(시리얼번호)
    Lot numbers: 2317363, 2331806, 2331810, 2387975, 2387976, 2401982, 5637286, 5644605, 5660377, 5664629, 5826243, and 5826244.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Class II Recall - Worldwide Distribution --- USA including states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, PA ,SC, TN, TX, UT, VA, WA, and WI, and countries of Canada and Switzerland.
  • 제품 설명
    Low Profile U-Joint Driver for the SynFix Mini-Open System, Catalog number 03.802.231. || The Synthes SynFix LR is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The interior of the spacer component of the SynFix LR can be packed with autograft.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Synthes Spine, 1302 Wrights Ln E, West Chester PA 19380-3417
  • 제조사 모회사 (2017)
  • Source
    USFDA