Medical DeviceMar 18, 2026
International Life Sciences Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor recall — FDA Z-1556-2026
Augmentation devices failed bacterial endotoxin testing.
Class IIFDA: OngoingInternational Life Sciences
Recall history in this database
Classification mix: Class II: 1.
Understanding this recall history
This page summarizes recall records in which the official source identifies International Life Sciences as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.