Artelon FlexBand Plus augmentation devices recalled for bacterial endotoxin contamination
International Life Sciences is recalling Artelon FlexBand Plus augmentation devices (Ref: 41054 and 41057) because they failed bacterial endotoxin testing. These devices may contain harmful bacterial contamination that could cause infection or other complications if implanted.
From the FDA notice · Read the official notice ↗
What to do
- Stop using affected devices immediately if you have them in stock or in use
- Check the lot numbers: A10010201 (Ref: 41054) or A10010101 (Ref: 41057)
- Contact your healthcare provider or facility if you have had this device implanted
- Return unused devices to International Life Sciences or your supplier for instructions
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Artelon FlexBand Plus Ref: 41054 & 41057
- Sold in
- Nationwide
- Made for
- All ages
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-1555-2026
In the FDA's words
- Description
- Artelon FlexBand Plus Ref: 41054 & 41057 Augmentation devices failed bacterial endotoxin testing. REF: 41054 -Lot: A10010201/GTIN: 00850003396064 REF: 41057 - Lot: A10010101/GTIN: 00850003396033 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 & 41057 (this page)Z-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