Artelon FlexBand Dynamic Matrix augmentation devices recalled for failed bacterial endotoxin testing
International Life Sciences is recalling Artelon FlexBand Dynamic Matrix augmentation devices (Ref: 31057) because they failed bacterial endotoxin testing. Bacterial endotoxins are substances that can trigger harmful immune responses. The devices were distributed worldwide, including throughout the United States and multiple international markets.
From the FDA notice · Read the official notice ↗
What to do
- Stop using the Artelon FlexBand Dynamic Matrix device immediately if you have one
- Contact your healthcare provider or the manufacturer for instructions on safe removal or replacement
- Do not discard the device without guidance from your medical team
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Artelon FlexBand Dynamic Matrix Ref: 31057
- Sold in
- Nationwide
- Made for
- Adults (0 months and older)
This recall covers 3 products — see all of them.
Details
- Units affected
- N/A
- Illnesses reported
- None reported
- Manufactured in
- 8601 Dunwoody Pl Ste 250, N/A, Atlanta, GA, United States
- Classification
- Class II
- Recall number
- Z-1554-2026
In the FDA's words
- Description
- Artelon FlexBand Dynamic Matrix Ref: 31057 Augmentation devices failed bacterial endotoxin testing. A10011001/GTIN: 00850003396019 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. Affected quantity: N/A
- Hazard
- Augmentation devices failed bacterial endotoxin testing.
3 products in this recall
Artelon FlexBand devices recalled for endotoxin test failures
International Life Sciences is recalling three Artelon FlexBand augmentation devices because they failed bacterial endotoxin testing. The recall covers three product listings and was distributed across the US and in several other countries. No injuries have been reported.
The agency lists each product separately. Check every one you might have.
- Artelon FlexBand Dynamic Matrix Ref: 31057 (this page)Z-1554-2026 · N/A
- Artelon FlexBand Plus Ref: 41054 & 41057Z-1555-2026 · N/A
- Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (Qty 1) 0.5x12cm FLEXBAND (Qty 1)Z-1556-2026 · N/A