Class 2 Device Recall iFuse TORQ Implant System

• Date Initiated by Firm: August 21, 2026
• Date Posted: October 09, 2026
• Recall Status: Open, Classified
• Recall Number: Z-0146-2027
• Recall Event ID: 99868
• 510(K)Number: K203247
• Product Classification: Sacroiliac joint fixation - Product Code OUR
• Product: iFuse TORQ Implant System Model/Catalog Number: 10055T(10x55mm), 10060T(10x60mm), 10065T(10x65mm), 10080T(10x55mm), 11580T(11.5x80mm)
• Code Information: 10055T-UDI:00810055520077/Lot:9142871 10060T-UDI:00810055520084/Lot:9137761 10065T-UDI:00810055520091/Lot:9139213 10080T-UDI:00810055520121/Lot:9137781 11580T-UDI:00810055520367/Lot:9142911
• FEI Number: 3007700286
• Recalling Firm/ Manufacturer: SI-BONE, Inc.; 471 El Camino Real Ste 101; Santa Clara CA 95050-4482
• For Additional Information Contact: Daniel Cher; 408-207-0700
• Manufacturer Reason for Recall: The pelvic fixation screws failed to meet acceptance criteria for tube packaging seal integrity testing; therefore, sterility assurance cannot be ensured.
• FDA Determined Cause: Packaging
• Action: On August 31, 2026 and September 2, 2026, SI-Bone, Inc. Chief Medical Officer spoke with affected surgeons via phone concerning the recall.
• Quantity in Commerce: 100 units
• Distribution: US Nationwide distribution in the states of FL, GA, HI, NC, OH, PA, SD, TX, VA.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = OUR