Events

Triathlon Navigation Tibial Alignment Handle 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Stryker Howmedica Osteonics Corp. 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
    61343
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1619-2012
  • 사례 시작날짜
    2011-10-10
  • 사례 출판 날짜
    2012-05-17
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-09-10
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108197
  • 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
    Stryker received a product experience report (per) that a swivel block was improperly oriented on a triathlon tibial alignment handle, catalog no. 6541-2-807.
  • 조치
    Stryker sent an Urgent Product Field Action letter dated October 10, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to contact their Stryker Sales Representative to arrange for return of the affected product . Customers were asked to fax back the attached Poroduct Field Action Acknowledgement Form as soon as possible to 201-831-6069. For any questions customers were instructed to call 201-972-2100. For questions regarding this recall call 201-831-3523.

Device

Triathlon Navigation Tibial Alignment Handle
  • 모델명 / 제조번호(시리얼번호)
    Catalog No.: 6541-2-807 N1A0l, N1K07 N1K14 N1N64 N1W04 N2A11 N2H10 N2L16 N2N04 N2V25 N2V26 N3E08 N3H12 N3H29 N3K02 N3K56 N3L13 N3S33 N3S39 N3T78 N3V21 N3W18 N3W29 N3W47 NYC02 NYC10 NYL09 NZC10 NZH09 NZL08 NZM01 NZS08 NZV09 customer Parts associated with cat. no. 6540-2-807 I-K2072AH00 - Triathlon Tibial Align. Handle with Secondary Lock I-K2336AH00 - Tibial Alignment Handle with Lock I-K2021TA00 - Triathlon Alignment Handle with Navigation Post I-K2059KT00 - Triathlon Tibia Alignment Handle I-K3254TA00 - Triathlon Tibial Alignment Handle with Lock I-K3251AH00 - Triathlon Tibial Alignment Handle for Sizes 1-3 I-K3113TH00 - Triathlon Tibial Alignment Handles (Augment) I-K2980 - Triathlon Tibia Alignment Handle I-K2954AH00 - Triathlon Tibia Alignment Handle I-K2916TA00 - Triathlon Tibial Alignment Handle I-K2797AH00 - Tibial Alignment Handle with no swivel Catalog No. 6541-2-8089 N1K14 N1N63 N1W08 N3K50 N3M43 N3T61 N3V56 N4E36
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and the countries of Asia Pacific, Canada, Europe, Middle East and Africa (EMEA), and Japan
  • 제품 설명
    Tibial Alignment Handle || Triathlon Instruments || CAT #: 6541-2-807 || Nav Tibial Alignment Handle Triathlon Instruments || CAT #; 6541-2-808 || Howmedica Osteonics Corp. || 325 Corporate Drive || Mahwah, NJ 07430 || The tibial alignment handles Cat# 6451-2-807 and 6541-2-808 are part of the Triathlon Knee Instruments set. The alignment handle is used after the tibial resection portion of a total knee arthroplasty procedure. The alignment handle helps holding and orienting the tibial template and trial, which are used to estimate the size and assess the orientation of the final implant. The implant will provide the new bearing surface of the knee, replacing the damaged joint.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

Stryker Howmedica Osteonics Corp.
  • 제조사 주소
    Stryker Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah NJ 07430
  • 제조사 모회사 (2017)
    Stryker
  • Source
    USFDA