Apatech Limited recalls Actifuse ABX/Actifuse MIS System A bone void filler intended only for orthopedic applications as a filler for gaps and…

Recall date

August 18, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1922-2016

FDA classification

Class II

Brand / firm

Apatech Limited

Sold / distributed

Worldwide Distribution: United States: Nationwide (including Puerto Rico) and countries of: Canada, Austria, Belgium, Switzerland, Germany, Denmark, Spain, Finland, France, Great Britain, Ireland, Italy, The Netherlands, Norway, Sweden, Slovenia, Czech Republic, Kuwait, Mexico, Brazil, Australia, T…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.