Device Recall Contender Postop Knee Brace Full Foam

  • Modèle / numéro de série
    (1) all braces that begin with a Revision Code of AN, AP, AQ, AR, AS, AT, AU are to be returned to Corflex immediately for review; (2) all braces with a Revision Code beginning with AM and that comply with the date range: Braces manufactured between September 1, 2015 and November 6, 2015
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) and Internationally to Canada , Taiwan , Singapore , and England.
  • Description du dispositif
    CONTENDER POST-OP-KNEE BRACE FULL FOAM || Model: 75-7550-000 || Post-Operative Knee Brace is indicated for range of motion control at the knee joint following ACL, PCL, MCL, and LCL surgeries, meniscal repairs, patella realignment, regenerative chondroplasty, stable femoral fractures, total knee replacements, and high tibial osteotomies.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Corflex, 669 E Ind Park Dr, Manchester NH 03109-5625
  • Société-mère du fabricant (2017)
  • Source
    USFDA