Device recall
iFuse TORQ Implant System Model/Catalog Number: 10055T(10x55mm), 10060T(10x60mm), 10065T(10x65mm), 10080T(10x55mm), 11580T(11.5x80mm)
- Recall number
- Z-0146-2027
- Event id
- 99868
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- SI-BONE, Inc.
- Report date
- Oct 21, 2026
- Posted
- Oct 9, 2026
- Initiated
- Aug 21, 2026
- Center classification date
- Oct 9, 2026
- Product code
- OUR
- Device type
- Sacroiliac Joint Fixation
- Reason
- The pelvic fixation screws failed to meet acceptance criteria for tube packaging seal integrity testing; therefore, sterility assurance cannot be ensured.
- Root cause
- Packaging
- Quantity
- 100 units
- 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
- Distribution
- US Nationwide distribution in the states of FL, GA, HI, NC, OH, PA, SD, TX, VA.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K203247
- Location
- Santa Clara, CA, United States