Artelon FLEXBAND TWIST surgical augmentation device recalled for bacterial endotoxin contamination
International Life Sciences is recalling Artelon FLEXBAND TWIST surgical augmentation devices (lot RK29976) because they failed bacterial endotoxin testing. Bacterial endotoxins are substances that can trigger harmful immune responses if present on medical devices used in surgery.
From the FDA notice · Read the official notice ↗
What to do
- If you have this device in inventory, quarantine it immediately and do not use
- Contact your supplier or International Life Sciences for return instructions
- Review your records to identify any patients who may have received this lot
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (Qty 1) 0.5x12cm FLEXBAND (Qty 1)
- Sold in
- Nationwide
- Made for
- Adults (18 years to 100 years)
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-1556-2026
In the FDA's words
- Description
- Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (Qty 1) 0.5x12cm FLEXBAND (Qty 1) Augmentation devices failed bacterial endotoxin testing. Lot: RK29976/GTIN: 00850003396248 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: 31057Z-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) (this page)Z-1556-2026 · N/A