Events

Device Recall OCM Cutting Burrs (Cutters) 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 The Anspach Effort, 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
    73738
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1667-2016
  • 사례 시작날짜
    2016-03-28
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-12-14
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144836
  • 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
    Drill, surgical, ent (electric or pneumatic) including handpiece - Product Code ERL
  • 원인
    Certain lots of the otologic curved micro (ocm) diamond ball burrs may be missing the diamond coating and the ball may be the incorrect size.
  • 조치
    Consignees were sent an Urgent Notice of this Medical Device Recall on 3/28/2016 for their product Otologic Curved Micro (OCM) Diamond Ball Burr, with the following actions required: We have record that your facility has the product(s) subject to this recall (removal). DePuy Synthes asks that you review your inventory and immediately remove the affected lots from stock. Please take the following actions: If you DO HAVE any of the identified devices, please take the following steps: 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. Please contact Product Support at (800) 327-6887, option 1, to arrange for return of any unused product. A credit will be issued for returned product. Send a copy of the completed Verification Section (page 3) to Product Support by fax to (561) 627-2682. Send a copy of the completed Verification Section (page 3) to the Complaint Handling Unit by scan/email to RA-DPYUS-chu.pb@ITS.JNJ.com. If you DO NOT HAVE the identified product, please take the following steps: Complete the Verification Section 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 recall (removal) information. ¿ Return the documents to The Anspach Effort by: ¿ Fax: (561) 627-2682 ¿ Scan/email: RA-DPYUS-chu.pb@ITS.JNJ.com ¿ Giving them to your DePuy Synthes Sales Consultant ¿ 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 of the notification.

Device

Device Recall OCM Cutting Burrs (Cutters)
  • 모델명 / 제조번호(시리얼번호)
    Model/Catalog #:OCM7-15SD, 1.5 MM Diamond Ball, Lot Numbers: J473111704 and J473111705
  • 의료기기 분류등급
    Ear, Nose, and Throat Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution in the states of KY and TX.
  • 제품 설명
    ANSPACH, Rx only, Otologic Curved Micro (OCCM) Diamond Ball Burr, 1.5 MM, Part # OCM7-15SD || Product Usage: || The Otologic Curved Micro (OCCM) Attachment and burrs are intended for cutting and shaping bone primarily in otology procedures such as cochleostomies.
  • Manufacturer
    The Anspach Effort, Inc.

Manufacturer

The Anspach Effort, Inc.
  • 제조사 주소
    The Anspach Effort, Inc., 4500 Riverside Dr, Palm Beach Gardens FL 33410-4235
  • 제조사 모회사 (2017)
    Johnson & Johnson
  • Source
    USFDA