Recall Z-0146-2027 · OUR Sacroiliac Joint Fixation
SI-BONE, Inc.
iFuse TORQ Implant System Model/Catalog Number: 10055T(10x55mm), 10060T(10x60mm), 10065T(10x65mm), 10080T(10x55mm), 11580T(11.5x80mm)
| Date | Oct 9, 2026 (initiated Aug 21, 2026) |
| Status | Open, Classified |
| 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 |
| Action | On August 31, 2026 and September 2, 2026, SI-Bone, Inc. Chief Medical Officer spoke with affected surgeons via phone concerning the recall. |
| Quantity | 100 units |
| Distribution | US Nationwide distribution in the states of FL, GA, HI, NC, OH, PA, SD, TX, VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K203247 | iFuse-TORQ Implant System SI-BONE, Inc., Feb 25, 2021 |