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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