Events

Synthes Soft Tissue Retractor Small Extendible 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Synthes USA HQ, 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
    66529
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0341-2014
  • 사례 출판 날짜
    2013-11-18
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-06-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122552
  • 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
    Retractor - Product Code GAD
  • 원인
    The potential exists for the locking screw nut to break on the soft tissue retractor if it is overt-tightened.
  • 조치
    Synthes sent an Urgent Notice: Medical Device Recall letter dated July 31, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review their inventory and immediately remove the affected lots from stock, call Synthes at 1-800-479-6329 to obtain a Return Authorization Number. Complete the Verification Section at the letter by checking the appropriate box indicating affected product has been located and return the Verification Form with the product to Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132. If customers do not have the identified product, they were instructed to complete the Offset blade facilitates easy preparation of the epipereosteal cavity for percutaneous plate insertion.e attached Verification Section and return to Synthes.

Device

Synthes Soft Tissue Retractor Small Extendible
  • 모델명 / 제조번호(시리얼번호)
    Part # Lot # 325.01 1776332 325.01 1834589 325.01 1855361 325.01 1893067 325.01 1903596 325.01 1952258 325.01 1986932 325.01 3067805 325.01 3150691 325.01 3179456 325.01 3186865 325.01 3220973 325.01 3241083 325.01 3268079 325.01 3360992 325.01 3719234 325.01 3818913 325.01 4948929 325.01 4994679 325.01 4994680 325.01 5031083 325.01 5031085 325.01 5391773 325.01 5420979 325.01 5420980 325.01 5476369 325.01 5476370 325.01 5510070 325.01 5544585 325.01 5546329 325.01 5563699 325.01 5569041 325.01 5624246 325.01 5657366 325.01 5677289 325.01 5759764 325.01 5759765 325.01 5779363 325.01 7698954 325.01 7826103
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (Nationwide) and Canada.
  • 제품 설명
    Synthes Soft Tissue Retractor Small Extendible || Offset blade facilitates easy preparation of the epipereosteal cavity for percutaneous plate insertion.
  • Manufacturer
    Synthes USA HQ, Inc.

Manufacturer

Synthes USA HQ, Inc.
  • 제조사 주소
    Synthes USA HQ, Inc., 1302 Wrights Ln E, West Chester PA 19380-3417
  • 제조사 모회사 (2017)
    Johnson & Johnson
  • Source
    USFDA