FDA-Device2026-03-18Class II
Artelon FlexBand Dynamic Matrix Ref: 31057
International Life Sciences
Hazard
Augmentation devices failed bacterial endotoxin testing.
Sold states
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.
Affected count
N/A
Manufactured in
8601 Dunwoody Pl Ste 250, N/A, Atlanta, GA, United States
Products
Artelon FlexBand Dynamic Matrix Ref: 31057
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1554-2026Original summary
Artelon FlexBand Dynamic Matrix Ref: 31057 Augmentation devices failed bacterial endotoxin testing. A10011001/GTIN: 00850003396019 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. Affected quantity: N/A
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