SI-BONE iFuse TORQ Implant System
The iFuse TORQ Implant System may not be sterile because its packaging seal integrity was not assured.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
SI-BONE, Inc. is recalling the iFuse TORQ Implant System because the pelvic fixation screws failed to meet acceptance criteria for tube packaging seal integrity testing, so sterility assurance cannot be ensured. The recall, which began August 21, 2026, was added to the FDA's Enforcement Report on October 9, 2026. The affected products include models 10055T, 10060T, 10065T, 10080T, and 11580T, totaling 100 units.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the list below, then check the codes the FDA notice also names.
iFuse TORQ Implant System
- Model
- 10055T
- 10060T
- 10065T
- 10080T
- 11580T
- UDI-DI
- 00810055520077
- 00810055520084
- 00810055520091
- 00810055520121
- 00810055520367
- Lot
- 9142871
- 9137761
- 9139213
- 9137781
- 9142911
From the FDA notice
Model/Catalog Number: 10055T(10x55mm), 10060T(10x60mm), 10065T(10x65mm), 10080T(10x55mm), 11580T(11.5x80mm)
Details
- Company began the recall
- Event ID
- 99868
- Company
- SI-BONE, Inc.
- Hazard
- Sterility failure
- Quantity recalled
- 100 units
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
