Device Recall Timberline Anchored Lateral Retractable Sleeve

  • 모델명 / 제조번호(시리얼번호)
    LOT Numbers: TU00053A, TU00053B and TU00118 Product Code: 86300205
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US Distribution to states of: AZ, CA, NY, TN and TX including PR.
  • 제품 설명
    Timberline Anchored Lateral Fixed Retractable Sleeve Model No. 8630-0205. Timberline Anchored Lateral Fixed Retractable Sleeves are used with the Timberline MPF System to help establish access into the vertebrae for the screws utilized to anchor the plate to the vertebrae. The Timberline Retractable Drill and the Timberline Retractable Awl fit within this Sleeve. || Spinal Surgical Device.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Biomet Spine, LLC, 310 Interlocken Pkwy Ste 120, Broomfield CO 80021-3464
  • 제조사 모회사 (2017)
  • 제조사 의견
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA