Events

Device Recall Vitagel 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Orthovita, Inc., dBA Stryker Orthobiologics. 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
    70609
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1353-2015
  • 사례 시작날짜
    2015-02-26
  • 사례 출판 날짜
    2015-03-30
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-07-28
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134154
  • 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
    Implant, dermal, for aesthetic use - Product Code LMH
  • 원인
    Several shipments of vitagel product (a surgical hemostat) required to be stored at 2 -8 degrees celsius (c) were not delivered to customers within the validated delivery time.
  • 조치
    Orthovita, Inc., dBA Stryker Orthobiiologics made phone notifications in February 2015 to all affected customers. Customers were told that the Vitagel they ordered on x date has an internal procedural mandate that says they must deliver in 35 hours and it has now passed that window. As a precaution until we can confirm that Vitagel delivered after shipping for longer is safe for use we are asking that they quarantine the order in question in the event the delivery occurs. For questions regarding this recall call 610-640-1775.

Device

Device Recall Vitagel
  • 모델명 / 제조번호(시리얼번호)
    Product Numbers: 2113-0000, 2113-0202 , 2113-0205; Lot Numbers: A1407061, A1406053, A1410055, A1501033, A1407037, A1412010, A1412076; Expiry Dates: 02/28/2017, 08/31/2016, 03/31/2017, 10/31/2016, 10/31/2016, 01/31/2017, 09/30/2016
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution including NY PA WV MI IL MA TX AR KS FL WI CA MO LA VA IA OH and NC.
  • 제품 설명
    Vitagel; indicated in surgical procedures (other than in neurosurgical and ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
  • Manufacturer
    Orthovita, Inc., dBA Stryker Orthobiologics.

Manufacturer

Orthovita, Inc., dBA Stryker Orthobiologics.
  • 제조사 주소
    Orthovita, Inc., dBA Stryker Orthobiologics., 45 Great Valley Pkwy, Malvern PA 19355-1302
  • 제조사 모회사 (2017)
    Stryker
  • Source
    USFDA