International Life Sciences

Device Recalls (Class II)

← All Device Recalls (Class II) Class II Z-1556-2026 · 20260318 · Ongoing

Product

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

Reason for Recall

Augmentation devices failed bacterial endotoxin testing.

Distribution

Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, M...

Source: openFDA Enforcement API