Device Recall 3DKnee HXL Tibial Insert

  • Modèle / numéro de série
    Lot # 292G1910
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution-US (nationwide) to states of: AL, TX, UT, and CA; and countries of: INDIA and GERMANY.
  • Description du dispositif
    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
  • 1 Event

Fabricant

  • Adresse du fabricant
    Encore Medical, Lp, 9800 Metric Blvd, Austin TX 78758-5445
  • Société-mère du fabricant (2017)
  • Source
    USFDA