Device Recall Cobalt HV Bone Cement

  • Model / Serial
    Lot Numbers: 508220, 189680, 199200, 310390, 424730, 6688130, 668150, 871240, 959720
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution
  • Product Description
    Cobalt HV Bone Cement 40GM, REF 402282, 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

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

2 devices with a similar name

Learn more about the data here

  • Model / Serial
    Lot Numbers: 507830, 871270, 959670
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution
  • Product Description
    Cobalt MV Bone Cement 40GM, REF 402438, 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
  • Model / Serial
    Lot Numbers: 189690, 189760, 199180, 424740, 508240, 560290, 595660, 638280, 786630, 959650, 959700
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • 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