SI-BONE, Inc. recalls iFuse TORQ Implant System
- Recalling company
- SI-BONE, Inc.
- Product
- iFuse TORQ Implant System Model/Catalog Number: 10055T(10x55mm), 10060T(10x60mm), 10065T(10x65mm), 10080T(10x55mm), 11580T(11.5x80mm)
- Reason
- The pelvic fixation screws failed to meet acceptance criteria for tube packaging seal integrity testing; therefore, sterility assurance cannot be ensured.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Aug 21, 2026
- Reported
- Oct 21, 2026
- Distribution
- US Nationwide distribution in the states of FL, GA, HI, NC, OH, PA, SD, TX, VA.
- Status
- Ongoing
- Quantity
- 100 units
- Lot / codes
- 10055T-UDI:00810055520077/Lot:9142871 10060T-UDI:00810055520084/Lot:9137761 10065T-UDI:00810055520091/Lot:9139213 10080T-UDI:00810055520121/Lot:9137781 11580T-UDI:00810055520367/Lot:9142911
- Company location
- Santa Clara, CA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-0146-2027
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0146-2027 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.