Events

Device Recall 3DKnee HXL Tibial Insert 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Encore Medical, Lp 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
    77435
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2658-2017
  • 사례 시작날짜
    2017-05-31
  • 사례 상황
    Completed
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=156052
  • 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
    Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
  • 원인
    Mis-pack. a size 6 left 3dknee tibial insert box and pouch contained a size 8 right 3dknee tibial insert.
  • 조치
    The firm, DJO Global, sent an "URGENT FIELD SAFETY NOTICE" dated 5/31/2017 by email to its consignees on 5/31/2017. The notice described the product, problem and actions to be taken. The consignees were instructed to do the following actions by June 16, 2017: pass notice on to all those within the organization or to any organization where the affected product has been transferred; contact customer service at 1-800-456-8696 to place a replacement order and obtain shipment information; return all affected devices; and complete, sign and return the Acknowledgment and Receipt Form by email to: Desiree.Wells@djoglobal.com. The Regulatory Affairs department will follow-up via phone and email with non-responding consignees. If you have any questions, please contact Sr. Director Regulatory Affairs by phone at (760) 734-3551 or by email at Neeta.Sharma@djoglobal.com.

Device

Device Recall 3DKnee HXL Tibial Insert
  • 모델명 / 제조번호(시리얼번호)
    Lot # 292G1910
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution-US (nationwide) to states of: AL, TX, UT, and CA; and countries of: INDIA and GERMANY.
  • 제품 설명
    3DKNEE(TM) SYSTEM e+, tibial Insert, LEFT Sz 6 / 11mm, REF 391-11-706, QTY 01, || The 3DKnee Insert HXL Tibial Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused with pure liquid pharmaceutical grade alpha-tocopheral and then cross-linked to conform to ASTM F2695. This insert is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along the lateral condyle.
  • Manufacturer
    Encore Medical, Lp

Manufacturer

Encore Medical, Lp
  • 제조사 주소
    Encore Medical, Lp, 9800 Metric Blvd, Austin TX 78758-5445
  • 제조사 모회사 (2017)
    The Blackstone Group LP
  • Source
    USFDA