FDA-Device2026-03-18Class IIPROCESSING DEFECT
Artelon FlexBand Dynamic Matrix augmentation devices recalled for failed bacterial endotoxin testing
OTHERNationwide distribution
Stop using Artelon FlexBand Dynamic Matrix devices
International Life Sciences is recalling Artelon FlexBand Dynamic Matrix augmentation devices (Ref: 31057) because they failed bacterial endotoxin testing. Bacterial endotoxins are substances that can trigger harmful immune responses. The devices were distributed worldwide, including throughout the United States and multiple international markets.
- Stop using the Artelon FlexBand Dynamic Matrix device immediately if you have one
- Contact your healthcare provider or the manufacturer for instructions on safe removal or replacement
- Do not discard the device without guidance from your medical team
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-1554-2026More International Life Sciences recalls
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