FDA-Device2026-03-18Class IIPROCESSING DEFECT
Artelon FLEXBAND TWIST surgical augmentation device recalled for bacterial endotoxin contamination
What this means
International Life Sciences is recalling Artelon FLEXBAND TWIST surgical augmentation devices (lot RK29976) because they failed bacterial endotoxin testing. Bacterial endotoxins are substances that can trigger harmful immune responses if present on medical devices used in surgery.
- If you have this device in inventory, quarantine it immediately and do not use
- Contact your supplier or International Life Sciences for return instructions
- Review your records to identify any patients who may have received this lot
The agency's original wording
Hazard
Augmentation devices failed bacterial endotoxin testing.
Intended for
Adults
Illnesses reported
None reported
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 TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (Qty 1) 0.5x12cm FLEXBAND (Qty 1)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1556-2026Want us to check the next one for you?
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