Z-1554-2026 Class II Ongoing

Recalled by International Life Sciences — Atlanta, GA

Recall Details

Product Type
Devices
Report Date
March 18, 2026
Initiation Date
February 6, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
N/A

Product Description

Artelon FlexBand Dynamic Matrix Ref: 31057

Reason for Recall

Augmentation devices failed bacterial endotoxin testing.

Distribution Pattern

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.

Code Information

A10011001/GTIN: 00850003396019