FDAAugust 18, 2015device
Actifuse ABX/Actifuse MIS System A bone void filler intended only for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Baxter Healthcare is issuing a voluntary recall for all lots of Actifuse ABX and Actifuse MIS System products with expiry before July 29, 2017 due to the possibility that the products may have endotoxin levels above specification criteria.
What to do
FDA enforcement status: Terminated
Brands named
apatech
UPCs
506005078050506005078051506005078052506005078058506005078060506005078070506005078072
Recall history
No related federal recalls on record for this brand yet.
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