FDA-Device2026-10-21Class IIPACKAGING DEFECT
SI-BONE iFuse TORQ pelvic fixation screws recalled for sterility assurance failure
Nationwide distributionMedical devices
What this means
SI-BONE discovered that pelvic fixation screws in certain iFuse TORQ Implant System models failed packaging seal integrity testing. This means sterility cannot be guaranteed for the affected units. No injuries have been reported.
- If you received one of the affected screws (check your lot number against the FDA notice), contact your surgeon or SI-BONE immediately.
- Do not use an affected unit until you have confirmed it with your healthcare provider.
- Review the FDA recall notice for the complete list of affected lot numbers and UDI codes.
The agency's original wording
Hazard
The pelvic fixation screws failed to meet acceptance criteria for tube packaging seal integrity testing; therefore, sterility assurance cannot be ensured.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of FL, GA, HI, NC, OH, PA, SD, TX, VA.
Affected count
100 units
Manufactured in
471 El Camino Real Ste 101, Santa Clara, CA, United States
Products
iFuse TORQ Implant System Model/Catalog Number: 10055T(10x55mm), 10060T(10x60mm), 10065T(10x65mm), 10080T(10x55mm), 11580T(11.5x80mm)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0146-2027Want us to check the next one for you?
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