Events

RTI Surgical Streamline OCT OccipitoCervicoThoracic Spinal Rod 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
    75242
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0290-2017
  • 사례 시작날짜
    2016-09-16
  • 사례 출판 날짜
    2016-10-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-06-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149750
  • 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 interlaminal - Product Code KWP
  • 원인
    Rti surgical inc. (rti) is conducting a voluntary recall on two specific lots of the streamline¿ oct straight rod, cocr. 3.2mm (d) x 240mm (l) due to the potential for small cracks to be present on the rods. the small cracks on the rods used in implants could cause reduced strength of these affected implants, and lead to patient injury.
  • 조치
    RTI issued e-mail cutsomer notices for their voluntary recall of lots 234829 and 234829 of the Streamline¿ OCT Straight Rod, CoCr, 3.2mm (D) x 240mm (L) on 09/16/2016. RTI Surgical has produced replacement implants that have been verified as not containing any cracks. These implants will be sent to customers once they have identified how many replacements are needed. Please follow the below instructions. 1. Review inventory located in your facility and any other point of use locations that you may be responsible for. Immediately quarantine any implants listed in this recall notice. Please refer to the pictures included in customer notices for the etch location of the lot numbers for these implants: 2. Contact the RTI Surgical Field Inventory representative Jennifer Mannor so that replacements can be sent and an RGA and return shipping labels can be created if needed. 3. Review, complete and return the attached recall reply form to Dan Nelson (dnelson@rtix.com) in accordance with the directions on the business reply form within 5 business days of receipt of this notification. Should customers have any questions please do not hesitate to contact RTI Surgical Field Inventory representative Jennifer Mannor (Email: jmannor@rtix.com Phone: 906-225-5872.

Device

RTI Surgical Streamline OCT OccipitoCervicoThoracic Spinal Rod
  • 모델명 / 제조번호(시리얼번호)
    Part Number: 23-CC-ROD-240; Lot Number: 234829, UDI Number: (01)0084646802 7179( 10}234829; Lot Number: 246678, UDI Number: {01}00846468027179{10}246678
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US Nationwide Distribution in the states of: AL, CA, CO, FL, IN, IL, MI, MO, MS, NC, NY, OK, TN, TX, and VA,.
  • 제품 설명
    RTI Surgical Streamline OCT Occipito-Cervico-Thoracic Spinal Rod, CoCr, 3.2mm (D) x 240mm (L) || Product Usage: || When intended to promote fusion of the cervical spine and occipitocervico-thoracic junction (occiput-T3), the Streamline OCT Occipito-Cervico-Thoracic System is intended for: degenerative disc disease (as defined by neck or back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture/ dislocation, atlanto/axial fracture with instability, occipito-cervical dislocation, deformities or curvature, tumors, pseudoarthrosis, and revision of previous cervical and upper thoracic spine surgery. The occipital bone screws are limited to occipital fixation only. The use of the pedicle screws (standard and high angle) is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. The pedicle screws are not intended for use in the cervical spine. The hooks, connectors, and rods are also intended to provide stabilization to promote fusion following reduction of fracture/ dislocation or trauma in the cervical/ upper thoracic (C1-T3) spine.
  • 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