Events

T5766 Offset Reamer Handle 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Greatbatch Medical 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
    76236
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1190-2017
  • 사례 시작날짜
    2016-10-19
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152568
  • 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
    Orthopedic manual surgical instrument - Product Code LXH
  • 원인
    On june 14, 2016, greatbatch discovered a significant increase in the number of field complaints for the t5766 offset reamer handle in which the u-joints of the drive chain component seizes during orthopedic procedures rendering the device non-functional. the 2016 failure rate for this failure exceeds the occurrence rate as defined in the dfmea.
  • 조치
    Consignee was sent via e-mail on 10/16/2016 a Greatbatch "Urgent Medical Device Recall" letter dated 10/19/2016 The letter described the purpose of the letter, Reason for Notification, Risk to Health, Recommendation, Instruction to Zimmer. Advised consignee to examine their inventory, quarantine the product and provide a list of the affected countries where the product was distributed. Also requested consignee to complete the Customer Notification Response form and return to Greatbatch at FieldActionCenter@Greatbatch.com. For questions contact your local Greatbatch Medical representative, Monday through Friday via telephone at 1-763-951-8235 8:00 AM (CT) to 5:00 PM (CT), or e-mail us at FieldActionCenter@Greatbatch.com .

Device

T5766 Offset Reamer Handle
  • 모델명 / 제조번호(시리얼번호)
    2481193, 2468380, 2599785, 2463309, 2468379, 2468398, 2468397, 2599516, 2671555, 2599517, 2670543, 2671558, 2734809, 2814828, 2814829, 2824496, 2858434, 2865404, 3030658, 2944397, 2977852, 2967214, 3000586, 3000590, 3030658, 3044689, 3071903, 3135658, 3088675, 3107504, 3188688, 3385844, 3188690, 3387046, 3397768.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide in the states of IN and the countries of Canada, Austria, Germany, Japan.
  • 제품 설명
    Offset Reamer Handle, T5766 || Product Usage: || The reamer handles are re-usable surgical instruments used in arthroplasty surgery of the hip joints, where either total joint replacement or resurfacing surgery is performed using a reamer cutting instrument. The reamer handles are intended for use with a surgical driver (active device). The reamer handle is connected at the distal end to a reamer. The T5766 reamer handle is an offset design with a drive shaft mechanism that spins on roller bearings and is encapsulated in an inner clam shell housing that is constrained within a Radel¿ tube and outer housing.
  • Manufacturer
    Greatbatch Medical

Manufacturer

Greatbatch Medical
  • 제조사 주소
    Greatbatch Medical, 2300 Berkshire Ln N, Plymouth MN 55441-4575
  • 제조사 모회사 (2017)
    Integer Holdings Corporation
  • Source
    USFDA