Device Recall Stryker Reflex Hybrid variable selfdrilling screw

  • 모델명 / 제조번호(시리얼번호)
    All Product with the following Catalog Number/ Description: 48664010, Variable Angle Bone Screw Self Drilling, Diameter 4.0 x 10 mm; 48664012, diameter 4.0 x 12 mm; 48604014, diameter 4.0 x 14 mm; 48664016, diameter 4.0 x 16 mm; 48664018, diameter 4.0 x 18 mm.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution -- Including states of NC, OR, AZ, TN, CA, MA, MD, IL, GA, FL, NJ, NM, KY, LA, PA, MI, UT, MO, OK, KS, OH, MN, NE, IN, MT, TX, AL, CO and WI.
  • 제품 설명
    Stryker Reflex Hybrid variable self-drilling screw. || Non Sterile. || Manufactured by Stryker Spine SAS, Cestas, France. || Distributed in USA by Howmedica Osteonics Corp., Mahwah, NJ 07430.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Stryker Spine, 2 Pearl Ct, Allendale NJ 07401-1611
  • 제조사 모회사 (2017)
  • Source
    USFDA