Events

Device Recall Rotate, BulletTip, TPlus, Contact, Crossfuse, and CrossFuse II, Interbody Fusion/Vertebral Body Re 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 RTI Surgical, Inc. (dba Pioneer Surgical Technology, 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
    71424
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1916-2015
  • 사례 시작날짜
    2015-05-21
  • 사례 출판 날짜
    2015-06-26
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-10-29
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137744
  • 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
    Intervertebral fusion device with bone graft, lumbar - Product Code MAX
  • 원인
    Three lots of the bullet -tip vbr 13mm x 32 mm implants are mislabeled with a light green colored label, used for 16 mm trial instead of a lime green label, used for a 13 mm trial.
  • 조치
    RTI Surgical sent an" Urgent Medical Device Voluntary Recall " Notification dated May 21, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Immediate Actions: We are aware that one of this product was distributed to you. This one device has already been returned to RTI Surgical so no further action is needed. This notice is for your records. RTI takes this error seriously and has initiated a corrective and preventative action investigation to prevent recurrence. We apologize for any inconvenience this may have caused. For further questions please call (906) 226-4489.

Device

Device Recall Rotate, BulletTip, TPlus, Contact, Crossfuse, and CrossFuse II, Interbody Fusion/V...
  • 모델명 / 제조번호(시리얼번호)
    Part Number: 32-13-32 Lot: 200827 Expiration Date: 2019-12-18 Part Number: 30-T-13-6 Lot: 202726 Expiration Date: 2020-01-16  Part Number: 30-T-1036-13-6 Lot: 202582 Expiration Date: 2020-01-15
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US Distribution to the states of : FL and NY
  • 제품 설명
    Bullet-Tip PEEK VBR/IBF System, 32mm(l) 13mm(H) Implant 32-13-32 UDI (01)008464680341 08(17)191218(10)200827; T-Plus PEEK VBR/IBF System, 10mm(W) x 27mm(l) x 13mm(H) Implant, 6degree lordotic 30-T-13-6 UDI (01) 00846468032920(17) 200116(10) 202726; and T-Plus PEEK VBR/IBF System, 10mm(W) x 36 mm(l) x 13mm(H) Implant, 6degree lordotic 30-T-1036-13-6 UDI (01)00846468032760(17)200115(10)202582. These products are part of the lnterbody Fusion Vertebral || Body Replacement System to ensure stability of the spine and adequate compression of the implant.
  • Manufacturer
    RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

Manufacturer

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
  • 제조사 주소
    RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.), 375 River Park Cir, Marquette MI 49855-1781
  • 제조사 모회사 (2017)
    RTI Surgical Inc
  • Source
    USFDA