Si Bone recalls
Si Bone appears in 1 official U.S. recall notice indexed by RecallRadar, most recently on 2026-10-21.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 1 |
|---|---|
| Published | 2026-10-21 |
| By agency | FDA Device (1) |
| By classification | Class II (1) |
| By status | ongoing (1) |
| Distribution named in notices | US |
Recalls
- iFuse TORQ Implant System Model/Catalog Number: 10055T(10x55mm), 10060T(10x60mm), 10065T(10x65mm), 10080T(10x55mm), 11580T(11.5x80mm)
FDA Device · Class II · 2026-10-21 · Si Bone
Reason: The pelvic fixation screws failed to meet acceptance criteria for tube packaging seal integrity testing; therefore, sterility assurance cannot be ensured.