Device Recall Pull Reduction Device For 4.3mm Percutaneous Drill Guide 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Synthes, 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
    71364
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1799-2015
  • 사례 시작날짜
    2015-05-28
  • 사례 출판 날짜
    2015-06-15
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2016-08-22
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Guide, surgical, instrument - Product Code FZX
  • 원인
    Certain affected parts and lots of the pull reduction devices may have been manufactured to an incorrect hardness specification which could result in intraoperative breakage.
  • 조치
    DePuy Synthes sent an Urgent Notice Urgent notice dated May 28, 2015, to all affected customers to advise them of the defect and patient risks associated with its use. Customers were instructed if they have any of the identified devices, please take the following steps: ¿ Call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number. ¿ Complete the Verification Section (page 3 of this letter) by checking the appropriate box indicating affected product has been located. Also, please indicate the number of devices found and note the Return Authorization Number. Please include your name, title, address, telephone number and signature in the spaces provided. ¿ Return the Verification Section (page 3 of this letter) with the product to: ¿ Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132. ¿ Send a copy of the completed Verification Section by: ¿ Fax: (888) 943-5206 or ¿ Scan/email: Synthes2912@stericycle.com If you DO NOT have the identified product, please take the following steps: ¿ Complete the attached Verification Section (page 3 of this letter) by checking the appropriate box indicating that no affected product has been located. Please include your name, title, address, telephone number and signature in the spaces provided. This return documentation acknowledges your receipt of medical device removal information. ¿ Return the documents by: ¿ Fax: (888) 943-5206 or ¿ Scan/email: Synthes2912@stericycle.com ¿ Note: If the Verification Section is answered on behalf of more than one facility and/or individual, please clearly indicate the name and address of the facility and/or individual on page 3 of the notification. Customers with questions were instructed to call 610-719-5450. For questions regarding this recall call 610-719-5000.

Device

  • 모델명 / 제조번호(시리얼번호)
    Part Number: 03.120.023, with lot numbers:  1825699 1825946 1959344 1959346 3052800 3066995 3066996 3066997 3092693 3092737 3139434 3139480 3139483 3139485 3159152 3167363 3172147 3207364 3218030 3218068 3223545 3224270 3224271 3224275 3224581 3224582 3224583 3233445 3288206 3422091 3447606 3469240 3502469 3535235 3556421 3556422 3584316 3642892 3740917 3740919 3740920 3740924 3775480 3775482 3811200 7510644 7510645 7510647 7510648 7542178 7555756 7629268 7699116 7699117 7742370 7742371 7742372 7778806 7778807 7821741 7878176 7995396 8016667 8028575 8068778 8070887 8070891 8195690 8210669 8217914 8408715
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-US (nationwide) and internationlly to Canada
  • 제품 설명
    Pull Reduction Device For 4.3mm Percutaneous Drill Guide; The pull reduction device with quick coupling is placed through the guide sleeve and plate holes to pull or push bone fragments relative to the plate. This instrument can be used for: Minor Varus-valgus adjustments (approximately 2¿ - 4¿), Translational adjustments, Stabilization of plate bone orientation during insertion of the first screws, alignment of segmental fragments and pre-drilling dense or thick cortical bone before placing a 5.0 mm locking screw.
  • Manufacturer

Manufacturer

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