FDA DevicesClass II
Artelon FlexBand Plus Ref: 41054 & 41057
Published: March 18, 2026Recall ID: Z-1555-2026Category: devicesCountry: US
Reason for Recall / Hazard
Augmentation devices failed bacterial endotoxin testing.
Product Description & Identification
Artelon FlexBand Plus Ref: 41054 & 41057
Affected Products
Artelon FlexBand Plus Ref: 41054 & 41057
Additional Source Details
| Field | Value |
|---|---|
| City | Atlanta |
| State | GA |
| Event id | 98399 |
| Address 1 | 8601 Dunwoody Pl Ste 250 |
| Address 2 | N/A |
| Code info | REF: 41054 -Lot: A10010201/GTIN: 00850003396064 REF: 41057 - Lot: A10010101/GTIN: 00850003396033 |
| Postal code | 30350-2513 |
| Report date | 20260318 |
| Product type | Devices |
| Product quantity | N/A |
| Reason for recall | Augmentation devices failed bacterial endotoxin testing. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260206 |
| Initial firm notification | Letter |
| Center classification date | 20260311 |
Overview
- Recalling FirmInternational Life Sciences
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide - 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.