Events

Device Recall Instrument Kit for use with OsteoSponge SC grafts 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Bacterin International, Inc. 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
    70744
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1396-2015
  • 사례 시작날짜
    2015-03-09
  • 사례 출판 날짜
    2015-04-07
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-07-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134592
  • 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
    Orthopedic manual surgical instrument - Product Code LXH
  • 원인
    Instrument kits for osteosponge sc grafts, osteolock facet stabilization dowel, and bacfast hd facet dowel have incorrect sterilization parameters in the ifu and on the lid of the kits. sterilization parameters for the steam gravity 121 degree c (250 f) cycle were not validated and the dry time for the steam pre-vacuum 132 degree c (270 f) cycle was omitted.
  • 조치
    The firm, Bacterin, sent a "VOLUNTARY PRODUCT REMOVAL NOTIFICATION" letter and Steps for Voluntary Removal instructions, dated 03/03/2015, to their consignees on 3/9/2015. The letter described the product, problem and actions to be taken. The Consignees were instructed to check with your Inventory and Central Supply Departments to determine if you have the Instrument Kit for use with OsteoLock Facet Stabilization Dowel and BacFast HD Dowel listed; immediately remove all affected product and segregate the product in a secure location for return to Bacterin International, Inc.; complete and return the Tracking Verification Form to Bacterin (even if they do not have affected product to return) to listed address, by email tkarlberg@bacterin.com or fax to 1-406-388-3380; indicate returned products on tracking/verification form; contact the firm via email at tkarlberg@bacterin.com or call 1-406-388-0480 ext. 131 from 8am to 5pm Mountain Time to obtain instructions for returning the Instrument Kits to Bacterin; package the returned goods and send to Bacterin International, Inc. 664 Cruiser Lane, Belgrade, MT 59714. Consignees with further questions about recall, please call Regulator Affairs Manager at 406-388-9480 ext. 128 or send email to cming@bacterin.com

Device

Device Recall Instrument Kit for use with OsteoSponge SC grafts
  • 모델명 / 제조번호(시리얼번호)
    SERIAL NUMBERS:  004, 005, 006, 009, 010, 011, 012, 018, 019, 020, 021, 022, 023, 024, 025, 026, 029, 30, 033, 036, 038, 040, 045, 048, 060, 063, 064, 065, 066, 067, 068, 069, 070, 071, 072, 073, 074, 075, 076, 077, 079, 081, 082, 083, 084, 085, 086, 087, 088, 089, 090, 091, 092, 093, 094, 095, 096, 097, 098, 099, 100, 101, and 102.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US Distribution in states of: Alabama, Arizona, Arkansas, Colorado, Florida, Georgia, Illinois, Indiana, Louisiana, Maryland, Michigan, Minnesota, Mississippi, Missouri, Nebraska, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Puerto Rico, Texas, and Virginia.
  • 제품 설명
    Instrument Kit for use with OsteoSponge SC grafts. The Instrument Kit is used to insert OsteoSponge SC grafts to fill bone defects in the subchondral region of articulating joints. || The Instrument Kit is used to establish and maintain a port of entry for arthroscopic instruments or for an open procedure. The kit is also used to insert the OsteoSponge¿ SC graft during surgery. Such procedures include, but are not limited to, subchondral bone repair. || Affected Part numbers are 6508 and 6511.
  • Manufacturer
    Bacterin International, Inc.

Manufacturer

Bacterin International, Inc.
  • 제조사 주소
    Bacterin International, Inc., 600 Cruiser Ln, Belgrade MT 59714-9719
  • 제조사 모회사 (2017)
    Xtant Medical Holdings, Inc.
  • Source
    USFDA