Quick Facts at a Glance
- Recall Date
- February 6, 2026
- Hazard Level
- HIGH
- Brand
- International Life Sciences
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- International Life Sciences
- Product type
- Orthopedic augmentation device
- Model numbers
- RK29976 / GTIN 00850003396248
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
February 6, 2026
Reported by FDA DEVICE
March 18, 2026
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Augmentation devices failed bacterial endotoxin testing.
What You Should Do
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
About This Product
Artelon FLEXBAND TWIST augmentation devices are used in orthopedic procedures to provide augmentation anchors. They are designed to support surgical constructs.
Why This Is Dangerous
Bacterial endotoxins detected in testing suggest potential contamination that could lead to infection risk in patients relying on these devices.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall could disrupt procedures and require evaluation or replacement of affected implants. The immediate action is to stop use and await manufacturer instructions.
Practical Guidance
How to identify if yours is affected
- 1) Confirm lot RK29976 on the device packaging
- 2) Verify GTIN 00850003396248 on the label
- 3) Check Ref TW012 in product documentation
- 4) Confirm worldwide distribution status via the recall notice
- 5) Contact the manufacturer for instructions
Where to find product info
FDA recall page: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1556-2026
What timeline to expect
Processing times for refunds/replacements are not specified in the recall notice. Expect updates from the manufacturer.
If the manufacturer is unresponsive
- Keep documentation of all communications
- Escalate to CPSC if the company is unresponsive
- Seek guidance from your healthcare provider for interim patient safety plans
How to prevent similar issues
- For future purchases, verify endotoxin controls and supplier certifications
- Maintain records for recalls and verify GTIN numbers during implantation procedures
- Work with manufacturers that provide clear recall communication and patient safety guidance
Documentation advice
Keep copies of the recall notice, lot/risk information, all correspondence with the manufacturer, and any medical records related to the affected devices
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Product Details
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.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Endotoxin testing failure detected in Artelon FLEXBAND TWIST augmentation devices
- Recall number: Z-1556-2026
- Brand: International Life Sciences
- Product: Artelon FLEXBAND TWIST augmentation device (Ref: TW012) with anchors and FLEXBAND pieces, 3
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Safety Guide
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