Reported Oct 21, 2026 · Ongoing · Updated Oct 26, 2026
iFuse TORQ Implant System Model/Catalog Number: 10055T(10x55mm), 10060T(10x60mm), 10065T(10x65mm), 10080T(10x55mm),…
SI-BONE, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SI-BONE, Inc. · 471 El Camino Real Ste 101 · Santa Clara, CA · 95050-4482
Is this the product you have?
- iFuse TORQ
- Implant System Model/Catalog Number
10055T(10x55mm)10060T(10x60mm)10065T(10x65mm)10080T(10x55mm)11580T(11.5x80mm)
- Lot codes and dates
- 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
- Amount recalled
- 100 units
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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