FDAFebruary 6, 2026device

Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (Qty 1) 0.5x12cm FLEXBAND (Qty 1)

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

The hazard

Augmentation devices failed bacterial endotoxin testing.

What to do

FDA enforcement status: Ongoing

Brands named

international life sciencesinternationalinternational life

UPCs

00850003396248

Recall history

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

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