Flash FinanceUS
After hours S&P 5007,549.94+2.35% Nasdaq25,253.14+2.74% Dow 3052,389.75+2.15% Russell 20002,840.81+3.15% Nasdaq-10027,907.62+3.40% MidCap 4003,715.23+3.13% SmallCap 6001,722.37+2.89% VIX19.92-22.31% 10Y Yield4.86+0.10% Close of Nov 09, 2026
AI brief of an SEC Form 8-K · SI-BONE, Inc. (SIBN)

SI-BONE recalls 98 iFuse TORQ implants over tube packaging sterility concern

Negative Impact 3 of 5 legal/regulatory Written later

SI-BONE initiated a voluntary recall on August 21, 2026, of 98 iFuse TORQ implants from specific lots because some tube packaging may not meet sterile-barrier criteria. The company expects a gross charge of up to approximately $150,000 in third and fourth quarter cost of goods sold, and says it does not expect third quarter revenue to be otherwise affected. Separately, the company extended its Santa Clara headquarters lease for October 2026 at $43,696 per month.

Key points

  • Recall covers 98 implants from specific lots; tube packaging was made between May 4 and May 15, 2026.
  • Two recalled implants were already used in patients; no infections or adverse events reported as of the filing date.
  • About 3,900 implants need repackaging and re-sterilization; up to approximately $150,000 gross charge expected in Q3 and Q4 cost of goods sold.
  • FDA was notified on August 31, 2026, and the company recommends a Class II classification; the Fourth Lease Amendment runs October 1 to October 31, 2026.

The filing

CompanySI-BONE, Inc. (SIBN)
Form8-K, current report
Filed with the SECSep 11, 2026, 4:05 PM ET
Accession number0001459839-26-000076

Items reported: 1.01 Material Definitive Agreement2.03 New Direct Financial Obligation8.01 Other Events

Read the filing on SEC.gov ↗

Written by AI on Nov 9, 2026, 10:08 AM ET, from this filing only. Written later: this filing was briefed after the fact, when past filings were added to the site, so the brief may be read with hindsight; the filing itself is the record of what was known on September 11, 2026.

Briefs are written by AI from the filing text and can contain mistakes — open the filing before acting on anything. Impact (1-5) and tone are the AI's reading of the filing for shareholders, not a price forecast. Not investment advice.