International Life Sciences recalled Artelon FlexBand Dynamic Matrix 31057 after endotoxin testing failures. The recall covers the augmentation device used in medical procedures. Patients and healthcare providers should stop using the device immediately and await manufacturer instructions.
Augmentation devices failed bacterial endotoxin testing.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact International Life Sciences or your healthcare provider for instructions. Notification method: Letter
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The Artelon FlexBand Dynamic Matrix is described as an augmentation device intended for tissue support in surgical procedures.
The recall is due to endotoxin testing failure in the augmentation device, which could pose infection-related risks if implanted.
This recall is not described as part of a broader industry pattern.
The recall could affect patients relying on this device and may require medical consultation and potential device replacement or monitoring.
FDA recall page and manufacturer letters; see also the recall URL above
Not specified by the recall; follow manufacturer communications
Retain recall letters, model numbers, serial numbers, and all correspondence with providers and the manufacturer
Model numbers: A10011001/GTIN: 00850003396019 Where sold: Worldwide distribution including US states 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; countries Australia, France, Germany, Italy, Japan, Korea, Spain, Switzerland, United Kingdom, United Arab Emirates, Slovenia When sold: Unknown Price: Unknown
No injuries or incidents have been reported.
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