Device Recall 3DKNEE

  • 모델명 / 제조번호(시리얼번호)
    Catalog number 333-02-106; Lot numbers 991141 and 991131
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Product was distributed domesically to the following states: IA, MA, OK, TX, FL, CA, and SD. Product was shipped to one distributor in Germany.
  • 제품 설명
    3DKnee System, Stemmed Tibia-Nonporous-3D, Size 6, Right, sterile. Manufactured by Encore Orthopeadics, 9800 Metric Blvd., Austin, Texas 78758
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Encore Medical, LP, 9800 Metric Blvd, Austin TX 78758
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 5 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Lot # 292G1910
  • 의료기기 분류등급
  • 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
  • 모델명 / 제조번호(시리얼번호)
    Lot # 339G1045
  • 의료기기 분류등급
  • 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, RIGHT Sz 8 / 11mm, REF 391-11-708, 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
  • 모델명 / 제조번호(시리얼번호)
    Lot #434322.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Device distributed to direct accounts in AZ, CA, FL, GA, MO, NJ, OK, SC, SD and TX. Foreign consignies located in Freiburg and Langelsheim, Germany.
  • 제품 설명
    Size 8 right 3DKnee Non-porous Baseplates (Catalog #333-02-108) joint knee replacement.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot #53906407
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Distribution --- country of Germany.
  • 제품 설명
    3DKNEE Tibial Insert Trial, Size 2, 13mm Right; Part #801-01-640; manufactured by Encore Medical, L.P., Austin, TX 78758. || Used in surgery to determine the correct size of 3DKnee component to implant that would allow for the best range of motion and joint stability.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Size 8, Left, Part # 333-01-108, Lot# A1000003
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Florida, Missouri, and Italy
  • 제품 설명
    3DKnee Baseplates, Size 8, Left, Part # 333-01-108, Lot# A1000003.
  • Manufacturer