FDAFDA recall Z-0146-2027 · Oct 21, 2026
SI-BONE, Inc.: iFuse TORQ Implant System Model/Catalog Number: 10055T(10x55mm) recall
Recall found
Product
iFuse TORQ Implant System Model/Catalog Number: 10055T(10x55mm), 10060T(10x60mm), 10065T(10x65mm), 10080T(10x55mm), 11580T(11.5x80mm)
Reason for recall
The pelvic fixation screws failed to meet acceptance criteria for tube packaging seal integrity testing; therefore, sterility assurance cannot be ensured.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- 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
- Quantity
- 100 units
- Distribution
- US Nationwide distribution in the states of FL, GA, HI, NC, OH, PA, SD, TX, VA.
- Recalling firm
- SI-BONE, Inc., Santa Clara, CA
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-08-21
Source: openFDA enforcement record Z-0146-2027 · search recall number Z-0146-2027 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 26, 2026, 8:14 PM EDT. The agency notice is the final word.