Device Recall Cobalt HV Bone Cement with Gentamicin

  • Model / Serial
    Lot Numbers: 189690, 189760, 199180, 424740, 508240, 560290, 595660, 638280, 786630, 959650, 959700
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Nationwide Distribution
  • Product Description
    Cobalt HV with Gentamicin, Cobalt Bone Cement 40GM, REF 402283, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS || Cobalt MV and HV Bone Cement is indicated for use as bone cement in arthroplastic procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when reconstructions is necessary because of osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, nonunion of fractures of the neck of the femur, sickle cell anemia osteoporosis, secondary severe joint destruction following trauma or other conditions (also far fixation of unstable fractures in metastatic malignancies), and revision of previous arthroplasty procedures
  • Manufacturer
  • 1 Event


  • Manufacturer Address
    Encore Medical, Lp, 9800 Metric Blvd, Austin TX 78758-5445
  • Manufacturer Parent Company (2017)
  • Source