FDAJune 26, 2017device
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...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement.
What to do
FDA enforcement status: Ongoing
Brands named
encore medical lpencoreencore medical
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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