United StatesArtelon FlexBand Dynamic Matrix (Ref: 31057), Artelon FlexBand Plus (Ref: 41054 & 41057; Lots A10011001/GTIN 00850003396019, A10010201/GTIN 00850003396064) and Artelon FLEXBAND TWIST .12 (Lot RK29976/GTIN 00850003396248; REF: TW012) manufactured by International Life Sciences are being recalled; affected items can be recognized by those reference numbers, lot numbers and GTINs. They were recalled because the augmentation devices failed bacterial endotoxin testing and were distributed worldwide, including across the United States and multiple other countries.
What's being recalled
Artelon FlexBand Dynamic Matrix Ref: 31057
Artelon FlexBand Plus Ref: 41054 & 41057
Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (Qty 1) 0.5x12cm FLEXBAND (Qty 1)
Recalling firm: International Life Sciences, Atlanta, GA, United States.
How to identify it
A10011001/GTIN: 00850003396019 REF: 41054 -Lot: A10010201/GTIN: 00850003396064 REF: 41057 - Lot: A10010101/GTIN: 00850003396033 Lot: RK29976/GTIN: 00850003396248
The hazard
Augmentation devices failed bacterial endotoxin testing.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
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.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)