Device Recall AEQUALIS HUMERAL NAIL DRILL BIT

  • 모델명 / 제조번호(시리얼번호)
    Lot numbers:  BA0112130 BA0114126 BA0114174 BA0114279 BA0114344 BA0115022 BA0115071 BA0115203 BA0117059 BA0117083 BA0117100 BA0117145 BA0177206 BA0215015 BA0215022 BA0215203 BA0312130 BA0315203 BA0412130 BA0415203 BA0515203 BA0615203
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution
  • 제품 설명
    AEQUALIS HUMERAL NAIL DRILL BIT, REF 7020140 || Product Usage: || The Aequalis Humeral Nail system is intended to provide temporary stabilization of various types of proximal and/or diaphyseal fractures of the humerus. Types of fractures include, but are not limited to, non-unions, malunions, malalignments, pathological fractures, and impending pathological fractures. Examples of specific indications according to AO classification include Type A-Fractures, dislocated, Type B Fractures, dislocated, Type C-Fractures, with intact humeral head, or Humeral Fractures according to Neer-Classification (2, 3 and 4 part fractures).
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Tornier, Inc, 10801 Nesbitt Ave S, Bloomington MN 55437-3109
  • 제조사 모회사 (2017)
  • Source
    USFDA