Events

Device Recall Stryker Reflex Hybrid Level Anterior Cervical Plate 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Stryker Spine 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    50783
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1958-2009
  • 사례 시작날짜
    2006-06-14
  • 사례 출판 날짜
    2009-08-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2009-08-20
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=77258
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Appliance, fixation, spinal intervertebral body - Product Code KWQ
  • 원인
    Design flaw: the design did not prevent over angulation of the screws when the recommended instrument, all in one guide, was not used.
  • 조치
    Stryker Spine issued an "Important Market Withdrawal" notice dated June 14, 2006. Consignees were advised to complete and return a Product Accountability Form via fax to 1-201-831-6069 prior to returning the affected product. Product return was to be performed during certain phase periods when upgrades were being shipped. For further questions, contact Stryker Spine at 1-201-831-5825.

Device

Device Recall Stryker Reflex Hybrid Level Anterior Cervical Plate
  • 모델명 / 제조번호(시리얼번호)
    All Product with the following Catalog Number/Description: 48650112, Reflex Hybrid one-level plate, size 12mm; 48650114m size 14 mm; 48650116, 16 mm; 48650118, size 18mm; 48650120, size 20 mm; 48650122, size 22 mm.  48650224, Reflex Hybrid Two-Level Plate, size 24 mm; 48650226, size 26 mm; 48650228, size 28 mm; 48650230, size 30 mm; 48650232, size 32 mm; 48650234, size 34 mm; 48650237, size 37 mm; 48650240, size 40 mm; 48650243, size 43 mm; 48650246, size 46 mm. 48650339, REflex Hybrid Three-Level Plate, Size 39 mm; 48650342, size 42mm; 48650345, suze 45 mm; 48650348, size 48 mm; 48650351, size 51 mm; 48650354, size 54 mm; 48650357, size 57 mm; 48650360, size 60 mm; 48650363, size 63 mm; 48650366, size 66 mm; 48650369, size 69 mm. 48650460, Reflex Hybrid four-Level Plate, size 60 mm; 48650464, size 64 mm; 48650468, size 68 mm; 48650472, size 72 mm; 48650476, size 76 mm; 48650489, size 80 mm; 48650484, size 84 mm.
  • 의료기기 분류등급
    Orthopedic Devices
  • 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 Level Anterior Cervical Plate; || Non Sterile; Manufactured by Stryker Spine SAS, Cestas, France. Distributed by Howmedica Osteonics Corp. Mahwah, NJ 07430.
  • Manufacturer
    Stryker Spine

Manufacturer

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