Atlanta, GA, United States
International Life Sciences recalls
1 recall recorded since 2018, most recently on 6 February 2026. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 6 February 2026
- Reason
- Augmentation devices failed bacterial endotoxin testing.
- 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,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1554-2026, Z-1556-2026, Z-1555-2026
- Artelon FlexBand Dynamic Matrix Ref: 31057
- Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (Qty 1) 0.5x12cm FLEXBAND (Qty 1)
- Artelon FlexBand Plus Ref: 41054 & 41057
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.