CLASS II ONGOING Device recall · Reported 21 Oct 2026 · FDA Enforcement Report
iFuse TORQ Implant System recalled by Si-bone
Si-bone is recalling iFuse TORQ Implant System, distributed nationwide in the US. The recall was initiated on 21 Aug 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0146-2027
- FDA event ID
- 99868
- Recalling firm
- Si-bone, Santa Clara, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 21 Aug 2026
- FDA classified
- 9 Oct 2026
- Reported
- 21 Oct 2026
- Type
- Voluntary: Firm initiated
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 21 Aug 2026 | Recall initiated by company | |
| 9 Oct 2026 | Classified by FDA | +49 days |
| 21 Oct 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The pelvic fixation screws failed to meet acceptance criteria for tube packaging seal integrity testing; therefore, sterility assurance cannot be ensured.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
iFuse TORQ Implant System Model/Catalog Number: 10055T(10x55mm), 10060T(10x60mm), 10065T(10x65mm), 10080T(10x55mm), 11580T(11.5x80mm)
Where it was distributed
US Nationwide distribution in the states of FL, GA, HI, NC, OH, PA, SD, TX, VA.
Nationwide FloridaGeorgiaHawaiiNorth CarolinaOhioPennsylvaniaSouth DakotaTexasVirginia
Questions about this recall
Why was it recalled?
The pelvic fixation screws failed to meet acceptance criteria for tube packaging seal integrity testing; therefore, sterility assurance cannot be ensured.
Which lots are affected?
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
Where was it sold?
US Nationwide distribution in the states of FL, GA, HI, NC, OH, PA, SD, TX, VA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 27 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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