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Encore Medical, Lp recalls Cobalt MV with Gentamicin, Cobalt Bone Cement 40GM, REF 402439, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS Cobal
Recalled November 15, 2017 · FDA recall Z-0066-2018 · Encore Medical
Hazard
Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement. · FDA Class II
Units
1815 units
Sold at
Nationwide Distribution
Description
Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement.
Product
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
Manufacturer(s)
Encore Medical, Lp
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →