secwatch.observer — SEC 8-K summary
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Issuer:     SI-BONE, Inc. (SIBN)
CIK:        0001459839
Form:       8-K
Filed at:   2026-09-11T20:05:40+00:00
Accession:  0001459839-26-000076
Event type: other_material
Sentiment:  negative
Materiality: 0.60
Item codes: 1.01, 2.03, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1459839/000145983926000076/0001459839-26-000076-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1459839/000145983926000076/sibn-20260821.htm
  HTML page:      https://secwatch.observer/filing/0001459839-26-000076

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer