FDA recall, , Moderate risk
International Life Sciences Artelon FlexBand Dynamic Matrix and FlexBand Plus
Artelon FlexBand devices failed bacterial endotoxin testing.
Summary by Recall Canary from the FDA notice
What happened
International Life Sciences of Atlanta, Georgia, recalled Artelon FlexBand Dynamic Matrix, Artelon Flexband Twist.12, and Artelon FlexBand Plus augmentation devices because they failed bacterial endotoxin testing. The recall began February 6, 2026, and was added to the FDA's Enforcement Report on March 11, 2026.
The products were distributed 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.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
3 products
Affected if its UDI-DI and lot code are listed under that product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Artelon FlexBand Dynamic Matrix Ref: 31057
- UDI-DI
- 00850003396019
Artelon FlexBand Twist .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (Qty 1) 0.5x12cm FlexBand (Qty 1)
- UDI-DI
- 00850003396248
- Lot code
- RK29976
Artelon FlexBand Plus Ref: 41054 & 41057
- UDI-DI
- 00850003396064
- 00850003396033
- Lot code
- A10010201
- A10010101
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution including in the states of Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, Wyoming and the countries of Australia, France, Germany, Italy, Japan, Korea, Spain, Switzerland, United Kingdom, United Arab Emirates, Slovenia.
- Company
- International Life SciencesAtlanta, Georgia
- Hazard
- Contamination
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98399
- Recall numbers
- Z-1554-2026 to Z-1556-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
