Events

Device Recall S TBone Plate; M TCompression Plate; 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
    50094
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1334-2011
  • 사례 시작날짜
    2006-05-26
  • 사례 출판 날짜
    2011-02-16
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-12-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74713
  • 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
    Plate, fixation bone - Product Code HRS
  • 원인
    A package labeled as a s t-bone plate, catalog number 57-05260, lot code g4m00f1576, may actually contain a m t-compression plate, catalog number 57-10250, lot code g4n00f1584 and vice versa.
  • 조치
    Stryker Orthopedics sent an Important Market Withdrawal letter dated May 26, 2006, by Federal Express to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory, including their hospital consignment location, to identify the product. If the affected product remained in its original packaging, customers were instructed to retrieve all of the affected product lots and return it to their branch or agency warehouse for reconcillation. Reconcile all product on the attached Product Accountability Form and fax a copy of the form to 201-831-6069 within 5 days of receipt of the notice. Customers were asked to return the affected product via Inter-Org Transfer and ship to Product Surveillance, Stryker Orthopaedics, 325 Corporate Drive, Mahwah, New Jersey, USA 07430-2104. Customers were also instructed to contact their Stryker Orthopaedics Customer Service representataive to re-order the product that they were returning. For questions regarding this recall call (201) 831-5825.

Device

Device Recall S TBone Plate; M TCompression Plate;
  • 모델명 / 제조번호(시리얼번호)
    S T-Bone Plate, Product number: 57-05260; Lot Code G4M 00F1576; M T-Compression Plate, Product number 57-10260; Lot Code G4N00F1584
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution
  • 제품 설명
    S T-Bone Plate; || M T-Compression Plate; || Manufactured and Distributed by Stryker Lebinger GmbH & Co. || Freiburg, Germany. || The Profyle System is intended for use in internal fixation of the bones of hand and wrist. Examples of these procedures may include but are not limited to replantation, lag screws techniques, joint fusion, corrective osteotomies, and the treatment of fractures
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

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