Cobalt MV with Gentamicin, Cobalt Bone Cement 40GM, REF 402439, 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
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot Numbers: 508250, 959680
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Encore Medical, Lp
- Reason for Recall:
- Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Cobalt MV with Gentamicin, Cobalt Bone Cement 40GM, REF 402439, 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
Product Codes/Lot Numbers:
Lot Numbers: 508250, 959680
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0066-2018
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