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SI-BONE recalls
1 federal recall on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for SI-BONE and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-10-21FDA-DeviceClass IISI-BONE iFuse TORQ screws recalled for sterility packaging failure
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.
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