Device Recall BLACKSTONE PILLAR SA PARTIAL VERTEBRAL BODY REPLACEMENT DEVICE

  • 모델명 / 제조번호(시리얼번호)
    Part number: 49-1100, Lot Number 17301-L125.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    United States (IA, NV, CO, AZ, NY, MD, IL, VA, MN, MI, NC, CT, LA, AR, GA, CA, MO, WA, OK and AL).
  • 제품 설명
    Orthofix Spinal Implants; Pillar SA PEEK Spacer System Instrument Case. || Case contents: Implant Insertion Instrument, Straight Tamp, Bone Awl Drill Guide, Straight Drill, U-Joint Driver with and without retention, Flex Shaft Driver, Trial Insertion Instrument, Drill Tips, Cover Plate Inserter, Cover Plate Driver, Cover Plate Holder, Ratcheting Handle, Torque Limiting Handle, Hex Driver, Distractors/Sizers, Sizers REF: 49-0021: Orthoflex Spinal Implants, 1211 Hamburg Tnpk, Suite 300, Wayne, NJ 07470. || The Pillar SA Implant Insertion Instrument is intended for intraoperative use in placing/inserting Pillar SA implants into a prepared interbody space.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Orthofix, Inc, 1720 Bray Central Dr, McKinney TX 75069-8207
  • 제조사 모회사 (2017)
  • Source
    USFDA