SI-BONE, Inc. filed a Form 8-K with the SEC on September 11, 2026, disclosing a voluntary recall of 98 iFuse TORQ implants due to a tube packaging sterility issue and a one-month extension of its Santa Clara headquarters lease.

Key Highlights

  • Voluntary recall initiated: On August 21, 2026, the company recalled 98 iFuse TORQ implants from specific lots whose tube packaging was manufactured between May 4, 2026 and May 15, 2026.
  • Sterility concern: The recall was initiated due to failure of some products' tube packaging to meet acceptance criteria as a sterile barrier, presenting a risk of infection that could lead to patient harm, including revision surgery.
  • Two implants already used: Of the 98 recalled implants, two had already been implanted in patients; as of the filing date, no infections or adverse events had been reported.
  • Broader repackaging scope: The company disclosed that approximately 3,900 implants in total will need to be repackaged and re-sterilized due to the packaging issue.
  • Expected charges: The company expects to record an aggregate gross charge of up to approximately $150,000 in third quarter and fourth quarter cost of goods sold.
  • Lease extended one month: The company and landlord BIXBY SPE FINANCE 11, LLC agreed to extend the lease for its 21,848-square-foot Santa Clara office through October 31, 2026, at a base rent of $43,696 per month.
  • FDA report submitted: The company submitted a report of correction and removal to the FDA on August 31, 2026, and recommended the action be classified as a Class II recall.

SI-BONE Initiates iFuse TORQ Recall and Extends Headquarters Lease

According to the filing, SI-BONE, Inc. (NASDAQ:SIBN) initiated a voluntary recall on August 21, 2026, covering 98 iFuse TORQ implants distributed to its field salesforce and customers. The affected implants came from specific lots with tube packaging manufactured between May 4, 2026 and May 15, 2026. The company disclosed that its tube packaging subcontract manufacturer notified it of the packaging failure on August 17, 2026, after periodic assessment of tube packaging integrity.

The filing states that two of the 98 recalled implants had already been used in patients, and the two implanting physicians were notified. As of the filing date, the company reported that no infections or adverse events had been reported in connection with those two procedures. Beyond the 98 distributed implants, the company disclosed that approximately 3,900 implants in total will require repackaging and re-sterilization, with the remainder held in the company's warehouse or within inventory managed by its implant manufacturer and described as quarantined or in the process of being quarantined. The company reported that it does not believe implants outside the recalled and quarantined lots are affected, based on additional testing by the tube manufacturer. The company said it anticipates seeking cost recovery from the tube manufacturer, but noted "no assurance can be given that any recovery will be obtained."

Separately, the filing discloses that on September 11, 2026, the company and landlord BIXBY SPE FINANCE 11, LLC entered into the Fourth Amendment to Lease for the company's corporate headquarters at 471 El Camino Real, Santa Clara, California, comprising 21,848 square feet of office space. The amendment extends the lease term for one month, commencing October 1, 2026 and expiring October 31, 2026, at a base rent of $43,696 per month. The company also agreed to continue paying its share of operating expenses and taxes through the expiration date. The filing contains forward-looking statements regarding the recall and related activities, which the company states are subject to risks and uncertainties as described in its cautionary language.

What Was Disclosed

SI-BONE reported a voluntary recall of 98 iFuse TORQ implants over a tube packaging sterility concern, with an expected gross charge of up to approximately $150,000, and separately disclosed a one-month lease extension for its Santa Clara headquarters at $43,696 per month.