SI-BONE announces voluntary recall of iFuse TORQ implants
核心洞察
SI-BONE initiated a voluntary recall of 98 iFuse TORQ (搜索) implants on August 21, 2026, after tube packaging made between May 4 and May 15 failed sterile barrier criteria.
Two recalled implants had already been used in patients; physicians were notified and no infections or adverse events have been reported.
About 3,900 implants including recalled lots and affected inventory will be repackaged and re-sterilized, with costs of up to roughly $150,000 expected in the third and fourth quarters.
SI-BONE has voluntarily recalled 98 iFuse TORQ (搜索) implants after determining that tube packaging manufactured between May 4 and May 15, 2026 failed to consistently meet sterile barrier criteria. The company said the packaging failure creates a potential infection risk and a possible need for revision surgery. Two of the recalled implants had already been used in patients, and the treating physicians were notified. As of the announcement, no infections or adverse events had been reported.
After being notified of the packaging failure on August 17, 2026, SI-BONE determined that approximately 3,900 implants, comprising the recalled lots and affected inventory still under its control, must be repackaged and re-sterilized. Non-distributed stock has been quarantined in the company's warehouse and at its manufacturer. SI-BONE expects to take up to roughly $150,000 in gross charges in the third and fourth quarters for recall, sorting and reprocessing costs, and does not foresee a material impact on third-quarter revenue or on implant availability for physicians.
The company has filed a correction and removal report with the U.S. Food and Drug Administration (搜索) and is continuing its investigation with its manufacturing partners.
Source: The Globe and Mail