Events

Device Recall Synthes Battery Power Line II Oscillator 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
    71659
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2345-2015
  • 사례 시작날짜
    2015-07-01
  • 사례 출판 날짜
    2015-08-05
  • 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=138616
  • 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
    Instrument, cutting, orthopedic - Product Code HTZ
  • 원인
    Saw head separated from the drive unit or began to come loose.
  • 조치
    DePuy Synthes sent an " Urgent Notice Medical Device Recall (Removal) letter dated July 1, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. ACTION REQUIRED: Our records show that your facility has the affected product(s) subject to this removal. The Anspach Effort, on behalf of DePuy Synthes asks that you review your inventory and immediately remove any affected BPLII Battery Oscillator devices from stock. In addition to this letter, your DePuy Synthes Sales Consultant has been provided with new product(s) to immediately replace the affected product(s). If you have any questions regarding this removal, please contact the Complaint Handling Unit Manager at 561-494-3673 or contact your DePuy Synthes Sales Consultant.

Device

Device Recall Synthes Battery Power Line II Oscillator
  • 모델명 / 제조번호(시리얼번호)
    Serial numbers: 100067, 100076, 100371, 100372, 100063, 100065, 100069, 100076, and 100055; Foreign: Item number 530.710 Serial numbers: 100020, 100026, 100039, 100248, 100254, 100257, 100263, 100265, 100269, 100270, 100293, 100296, 100307, 100313, 100315, 100339, and 100340.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Distribution to the states of : AR, LA, OH, and WA., and the countries of : China, France, Italy, Russia, South Africa, Switzerland, and United Kingdom.
  • 제품 설명
    Synthes Battery Power Line II Oscillator Model 530.710, orthopedic surgical power tool.
  • 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