Spinal FrontiersPowered by NSpinePelvic fixation screws failed tube-packaging seal-integrity testing, so sterility cannot be assured; about 100 units were shipped to nine US states. SI-BONE's chief medical officer contacted affected surgeons directly.
- Type
- Recall
- Company
- SI-BONE
- Device
- iFuse TORQ Implant System (cat. 10055T, 10060T, 10065T, 10080T, 11580T)
- Date
- 21 August 2026
- Jurisdiction
- US
- Classification
- FDA Class II recall (Z-0146-2027; 510(k) K203247)
- Source
- FDA Medical Device Recalls database
Read the official notice →Source checked
What to do
Act on the regulator's or manufacturer's own notice; this page is a summary, not an official safety channel. If a device has failed or harmed a patient, see Report a Device Problem for who to tell in your country.