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Home › FDA recalls › Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HE
CLASS II · ModerateFDA

International Life Sciences recalls Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor

📅 Feb 6, 2026 · 📍 Nationwide
Recalling company
International Life Sciences
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
Augmentation devices failed bacterial endotoxin testing.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Feb 6, 2026
Reported
Mar 18, 2026
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.
Status
Ongoing
Quantity
N/A
Lot / codes
Lot: RK29976/GTIN: 00850003396248
Company location
Atlanta, GA
Recall type
Voluntary: Firm initiated
Recall number
Z-1556-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1556-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.