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

SI-BONE, Inc.

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.

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