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International Life Sciences: Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (Qty 1) 0.5x12cm FLEXBAND (Qty 1)

Medical DevicesSource: FDA (device) · Date: 2026-03-18

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
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 / hazard
Augmentation devices failed bacterial endotoxin testing.
Classification
Class II
Status
Ongoing
Distribution / sold at
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.
Recall initiated
2026-02-06
Code info
Lot: RK29976/GTIN: 00850003396248
Product quantity
N/A
Voluntary mandated
Voluntary: Firm initiated
City
Atlanta
State
GA
Country
United States
Event id
98399
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