International Life Sciences issued an active recall of Artelon FLEXBAND TWIST augmentation devices. The devices were distributed worldwide, including nationwide in the United States. The recall concerns failures in bacterial endotoxin testing that could pose a infection risk; users should stop using the device and follow recall instructions from the manufacturer.
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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Artelon FLEXBAND TWIST augmentation devices are used in orthopedic procedures to provide augmentation anchors. They are designed to support surgical constructs.
Bacterial endotoxins detected in testing suggest potential contamination that could lead to infection risk in patients relying on these devices.
This recall is not part of a broader industry pattern.
The recall could disrupt procedures and require evaluation or replacement of affected implants. The immediate action is to stop use and await manufacturer instructions.
FDA recall page: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1556-2026
Processing times for refunds/replacements are not specified in the recall notice. Expect updates from the manufacturer.
Keep copies of the recall notice, lot/risk information, all correspondence with the manufacturer, and any medical records related to the affected devices
Model numbers: Lot RK29976 / GTIN 00850003396248. Sold worldwide with US distribution including 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 Australia, France, Germany, Italy, Japan, Korea, Spain, Switzerland, United Kingdom, United Arab Emirates, Slovenia. Sold date and price not disclosed.
No injuries or incidents have been reported.
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