iFuse TORQ Implant System Model/Catalog Number: 10055T recall (SI-BONE, Inc.)
Medical deviceClass IIOngoing
Summary: SI-BONE, Inc. is recalling 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.
What is being recalled
iFuse TORQ Implant System Model/Catalog Number: 10055T(10x55mm), 10060T(10x60mm), 10065T(10x65mm), 10080T(10x55mm), 11580T(11.5x80mm)
Why
The pelvic fixation screws failed to meet acceptance criteria for tube packaging seal integrity testing; therefore, sterility assurance cannot be ensured.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution in the states of FL, GA, HI, NC, OH, PA, SD, TX, VA. (states named: Florida, Georgia, Hawaii, North Carolina, Ohio, Pennsylvania, South Dakota, Texas, Virginia)
How to tell if yours is affected
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
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-0146-2027 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | August 21, 2026 |
| Reported | October 21, 2026 |
| Company | SI-BONE, Inc. |
| Company location | Santa Clara, CA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 100 units |
More recalls from SI-BONE, Inc. · all medical device recalls · recalls from August 2026