Events

Device Recall Inion Baby Screw 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Stryker Craniomaxillofacial Division 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
    55179
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1550-2010
  • 사례 시작날짜
    2010-03-05
  • 사례 출판 날짜
    2010-05-07
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-06-06
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90225
  • 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
    screw, fixation, plate, bone - Product Code HWC
  • 원인
    During a sampling inspection, 2 lots of screws did not meet shear and torsion testing specifications.
  • 조치
    The firm, Stryker, issued two "URGENT PRODUCT RECALL NOTIFICATION" letters, dated March 5, 2010 and March 19, 2010, to customers. The letters describe the product, problem and action to be taken by the customers. The customers were instructed to examine their inventory for the catalogue and lot numbers, return the enclosed confirmation indicating the location of the affected product, return any remaining product to Stryker at the noted address, and provide a copy of this notification to any site that they may have distributed the product to. If you have any further questions, contact Rob Yamashita, Sr. Regulatory Affairs Rep at (269) 323-4258 or email: rob.yamashita@stryker.com

Device

Device Recall Inion Baby Screw
  • 모델명 / 제조번호(시리얼번호)
    Lot numbers 0808009 and 0809069. Model number SCR1221.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide distribution: CA, CO, CT, FL, GA, IL, LA, MA, MD, ME, MO, MT, NC, NH, NJ, NM, NY, OH, PA, RI, SC, TX and WI.
  • 제품 설명
    Inion 1.5 x 6mm CPS(R) Baby Screw, 1.5mm Inion CPS(R) Baby 5+E, REF SCR 1221, 5/pack, STERILE/R Stryker Craniomaxillofacial, Portage, MI. || The INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM is a craniomaxillofacial plating system intended to maintain accurate alignment of bone fractures and osteotomies in the cranium and mid-face.
  • Manufacturer
    Stryker Craniomaxillofacial Division

Manufacturer

Stryker Craniomaxillofacial Division
  • 제조사 주소
    Stryker Craniomaxillofacial Division, 750 Trade Centre Way, Ste 200, Portage MI 49002-0482
  • 제조사 모회사 (2017)
    Stryker
  • Source
    USFDA