iFuse TORQ Implant System recallZ-0146-2027 · SI-BONE, Inc. · initiated Aug 21, 2026
Open, Classified All recalls posted in October 2026
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from SI-BONE, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The pelvic fixation screws failed to meet acceptance criteria for tube packaging seal integrity testing; therefore, sterility assurance cannot be ensured.
FDA root cause category: Packaging
What the company is doing
On August 31, 2026 and September 2, 2026, SI-Bone, Inc. Chief Medical Officer spoke with affected surgeons via phone concerning the recall.
Recall details
- Recall number
- Z-0146-2027
- Recall class
- Not yet classified by the FDA
- Status
- Open, Classified
- Initiated by the company
- Aug 21, 2026
- Posted by the FDA
- Oct 9, 2026
- Recalling firm
- SI-BONE, Inc.
- Quantity
- 100 units
- Product code
- OUR
- FDA submissions
- K203247
- Distribution
- US Nationwide distribution in the states of FL, GA, HI, NC, OH, PA, SD, TX, VA.
Product description
iFuse TORQ Implant System Model/Catalog Number: 10055T(10x55mm), 10060T(10x60mm), 10065T(10x65mm), 10080T(10x55mm), 11580T(11.5x80mm)
Code information (models, lots, serial numbers)
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
Devices named in this recall
5 devices in the FDA device registry whose identifier appears in the recall's code information.
- iFuse TORQ Implant System 10060TSi-Bone Inc. · Sacroiliac Joint Fixation1 recall1 report
- iFuse TORQ Implant System 10065TSi-Bone Inc. · Sacroiliac Joint Fixation1 recall1 report
- iFuse TORQ Implant System 10055TSi-Bone Inc. · Sacroiliac Joint Fixation1 recall0 reports
- iFuse TORQ Implant System 10080TSi-Bone Inc. · Sacroiliac Joint Fixation1 recall0 reports
- iFuse TORQ Implant System 11580TSi-Bone Inc. · Sacroiliac Joint Fixation1 recall0 reports
Product lines
Other devices under the same FDA submission
4 devices cleared under K203247 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- iFuse TORQ Implant System 10045TSi-Bone Inc. · Sacroiliac Joint Fixation1 report
- iFuse TORQ Implant System 10090TSi-Bone Inc. · Sacroiliac Joint Fixation1 report
- iFuse TORQ Implant System 10090LGSi-Bone Inc. · Sacroiliac Joint Fixation1 report
- iFuse TORQ Implant System 11555TSi-Bone Inc. · Sacroiliac Joint Fixation1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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