Events

Device Recall DePuy Mitek GRYPHON P BR DS Anchor w/ORTHOCORD 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 DePuy Mitek, Inc., a Johnson & Johnson Co. 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
    58037
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2210-2011
  • 사례 시작날짜
    2011-02-24
  • 사례 출판 날짜
    2011-05-19
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-02-20
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98058
  • 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
    Fastener, fixation, nondegradable, soft tissue - Product Code MBI
  • 원인
    Metal debris in the shaft component of the device.
  • 조치
    DePuy Mitek sent an Urgent Voluntary Product Recall Notification letter dated February 24, 2011, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to immediately check their inventory to determine if they have any affected product. Customers were asked to complete the enclosed business reply form and fax it to 508-828-3750 or email to mitekcomplaints@its.jnj.com whether or not they have any of the affected product remaining in their inventory. Customers were asked to utilize the return good authorization number provided by customer service and return all identified product to: DePuy Mitek ATTN: Recall Coordinator 50 Scotland Boulevard Bridgewater, MA 02324 For any questions call 1-877-379-4871 or contact DePuy Mitek Customer Service directly at 1-800-382-4682, PROMPT 3.

Device

Device Recall DePuy Mitek GRYPHON P BR DS Anchor w/ORTHOCORD
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers:  3449990 3451672 3452663 3453946 3455144 3455703 3456883 3462226 3468839 3473244 3476092 3476648 3477802 3478695 3479693 3484277 3486069 3477068 3494964 3495725
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA (nationwide) and the countries of Austrailia Austria Belgium Canada China Estonia Finland France Germany Great Britain Indonesia Ireland Italy Japan Lebanon Lithuania Netherlands Poland Singapore Slovenia South Africa Spain Sweden and Switzerland
  • 제품 설명
    DePuy Mitek GRYPHON P BR DS Anchor w/ORTHOCORD¿ || Product Code: 210813 || Gryphon BR Suture Anchors are intended for: Shoulder: Rotor Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction; Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair; Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, lliotibial Band Tenodesis; Elbow: Biceps Tendon Reattachment, UInar or Radial Collateral Ligament Reconstruction.
  • Manufacturer
    DePuy Mitek, Inc., a Johnson & Johnson Co.

Manufacturer

DePuy Mitek, Inc., a Johnson & Johnson Co.
  • 제조사 주소
    DePuy Mitek, Inc., a Johnson & Johnson Co., 325 Paramount Dr, Raynham MA 02767
  • 제조사 모회사 (2017)
    Johnson & Johnson
  • Source
    USFDA