Events

4.5mm PLEO Osteotomy Guide. 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 OrthoPediatrics Corp 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
    63554
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0432-2013
  • 사례 시작날짜
    2012-10-18
  • 사례 출판 날짜
    2012-11-22
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-09-18
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114199
  • 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
    Plate, fixation, bone - Product Code HRS
  • 원인
    Complaint received from sales representative that the drill guide tubes would not screw into replenishment instrument. upon investigation, it has been determined that the device was not manufactured to design specifications and will not function as intended.
  • 조치
    OrthoPediatrics sent an "URGENT RECALL" e-mail of the Trochar Scalpel Instrument to all affected customers. The e-mail identifies the product, problem, and actions to be taken by the customers. The e-mail states that the instrument has been manufactured incorrectly and will not work (function as intended). The threads in the instrument are faulty and the guide tubes will not thread in correctly. Customers will receive follow up information.

Device

4.5mm PLEO Osteotomy Guide.
  • 모델명 / 제조번호(시리얼번호)
    Part number: 01-1050-0066 and 01-1050-0067 Lot numbers: 7861001 and 7861101 only
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution-including the states of OH, NC, CO, FL, IN, MI, and TX.
  • 제품 설명
    4.5mm PLEO Osteotomy Guide. || OrthoPediatrics Corp. markets a pediatric, extension osteotomy bone plate system. This system is marketed under the brand name OrthoPediatrics PediLock Extension Osteotomy Plate ( PLEO ). The product included in this recall is a Class I, 4.5mm PLEO Osteotomy Guide Instrument, common name: Guide, Surgical, Instrument. The PediLoc¿ Extension Osteotomy Plate is part of the OrthoPediatrics~PediLoc¿ system. The PediLoc¿ Extension Osteotomy Plate consists of 3.5mm and 4.5mm plates, left and right side specific. The PediLoc¿ Extension Osteotomy Plate is designed to fit the anatomy of the distal femur in children and adolescents, above the distal femoral physis. The distal section of the plate is designed so that three locking screws can be placed in the distal bone segment at an angle parallel to the distal femoral physis. The proximal portion of the plate is designed to accept locking or non-locking screws. The subject instrument of this recall is an adjunct instrument for the convenience of some surgeons who choose to use it. This instrument is not illustrated in the Surgical Technique, nor required to perform the procedure.
  • Manufacturer
    OrthoPediatrics Corp

Manufacturer

OrthoPediatrics Corp
  • 제조사 주소
    OrthoPediatrics Corp, 2850 Frontier Dr, Warsaw IN 46582-7001
  • 제조사 모회사 (2017)
    Orthopediatrics Corp
  • Source
    USFDA