International Life Sciences
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