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FDAFebruary 11, 2015device

SMARTSET GHV Gentamicin Bone Cement. A self-curing, radiopaque, polymethyl methacrylate based cement containing antibiotic. It is used for securing a metal or polymeric prosthesis to living bone in arthroplasty procedures. The bone cement has no intrinsic adhesive properties but relies instead on...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

One lot of SMARTSET GHV Gentamicin Bone Cement is partially agglomerated . This may result in surgical delays while a replacement package of cement is retrieved and mixed.

What to do

FDA enforcement status: Terminated

Brands named

depuy orthopaedicsdepuy

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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