Class IIDeviceOngoing

SI-BONE, Inc.

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.

Details

Recall number: Z-0146-2027
Event ID: 99868
Recall initiated: Aug 21, 2026
Classified: Oct 9, 2026
Reported: Oct 21, 2026
Quantity: 100 units
Distribution: US Nationwide distribution in the states of FL, GA, HI, NC, OH, PA, SD, TX, VA.
Initiated by: Voluntary: Firm initiated
Firm location: Santa Clara, CA, United States
Lot / code info: 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