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International Life Sciences FDA Recalls

3 recalls on file across devices, 0 of them Class I and 3 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product
Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (Qty 1) 0.5x12cm FLEXClass IIFeb 6, 2026Augmentation devices failed bacterial endotoxin testing.
Artelon FlexBand Plus Ref: 41054 & 41057Class IIFeb 6, 2026Augmentation devices failed bacterial endotoxin testing.
Artelon FlexBand Dynamic Matrix Ref: 31057Class IIFeb 6, 2026Augmentation devices failed bacterial endotoxin testing.

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