- Recalling firm
- SI-BONE, Inc.
- Reason for recall
- The pelvic fixation screws failed to meet acceptance criteria for tube packaging seal integrity testing; therefore, sterility assurance cannot be ensured.
- Affected products (lot / model / serial)
- 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
- Units affected
- 100 units
- Distribution pattern
- US Nationwide distribution in the states of FL, GA, HI, NC, OH, PA, SD, TX, VA.
- Firm location
- Santa Clara, CA, United States
- Recall type
- Voluntary: Firm initiated
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-0146-2027
- Recall initiated
- August 21, 2026
- FDA classification date
- October 9, 2026
- FDA report date
- October 21, 2026
- FDA event ID
- 99868
- Last updated on HTM Vibe
- October 27, 2026
