International Life Sciences: Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
- Recalling firm
- International Life Sciences
- Product
- Artelon FlexBand Dynamic Matrix Ref: 31057
- Reason
- Augmentation devices failed bacterial endotoxin testing.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-02-06
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- 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,...
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/0eb2a2bc-0bef-4486-9dd1-dd0532d1e2a3