FDAFDA · Food and drugs·Recall number Z-0067-2018
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
Published November 15, 2017 · Recall initiated: June 26, 2017
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Encore Medical, Lp
- Distributor
- Nationwide Distribution
- Lot
- Lot Numbers: 189690, 189760, 199180, 424740, 508240, 560290, 595660, 638280, 786630, 959650, 959700
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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