---
schema_version: "secwatch.filing_event.v1"
accession: "0001459839-26-000076"
form_type: "8-K"
ticker: "SIBN"
cik: "0001459839"
company_name: "SI-BONE, Inc."
filed_at: "2026-09-11T20:05:40+00:00"
generated_at: "2026-09-11T20:07:16.070512+00:00"
event_type: "other_material"
sentiment: "negative"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# SI-BONE recalls 98 iFuse TORQ implants over sterility packaging failure

## Summary
- Voluntary recall of 98 iFuse TORQ implants from lots with tube packaging made May 4-15, 2026; 2 implanted, no infections reported.
- FDA notified Aug 31, 2026; recommended Class II recall; ~3,900 implants to be repackaged/re-sterilized.
- Expects gross charge up to ~$150K in Q3/Q4 COGS; seeks recovery from tube manufacturer.
- No material impact expected on Q3 revenue or ability to supply implants.
- Also extended office lease one month to Oct 31, 2026 at $43,696/month.

## SEC filing metadata
- accession: 0001459839-26-000076
- form_type: 8-K
- ticker: SIBN
- cik: 0001459839
- company_name: SI-BONE, Inc.
- filed_at: 2026-09-11T20:05:40+00:00
- event_type: other_material
- sentiment: negative
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 1.01, 2.03, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1459839/000145983926000076/0001459839-26-000076-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1459839/000145983926000076/sibn-20260821.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001459839-26-000076
- JSON: https://secwatch.observer/filing/0001459839-26-000076.json
- Plain text: https://secwatch.observer/filing/0001459839-26-000076.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.
