TemporaryFDAOngoing
Can cause harm that is usually temporary.
iFuse TORQ Implant System Model/Catalog Number: 10055T(10x55mm), 10060T(10x60mm), 10065T(10x65mm), 10080T(10x55mm), 11580T(11.5x80mm)
Check the device or its packaging for
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
- Why
- The pelvic fixation screws failed to meet acceptance criteria for tube packaging seal integrity testing; therefore, sterility assurance cannot be ensured.
- Distributed
- US Nationwide distribution in the states of FL, GA, HI, NC, OH, PA, SD, TX, VA.
- Company
- SI-BONE, Inc.
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-0146-2027 · retrieved 9 October 2026
Read the official notice