Artelon FlexBand Dynamic Matrix Ref: 31057
FDA Recall #Z-1554-2026 — Class II — February 6, 2026
Product Description
Artelon FlexBand Dynamic Matrix Ref: 31057
Reason for Recall
Augmentation devices failed bacterial endotoxin testing.
Recalling Firm
International Life Sciences — Atlanta, GA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
N/A
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, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WY and the countries of Australia, France, Germany, Italy, Japan, Korea, Spain, Switzerland, United Kingdom, United Arab Emirates, Slovenia.
Code Information
A10011001/GTIN: 00850003396019
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated