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iFuse TORQ Implant SystemRecalls & reported problems across all models

Si-Bone Inc. · 9 models in the FDA device registry

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names at least one iFuse TORQ Implant System model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.

Adverse event reports
6
Deaths reported
0
Injuries reported
6
Recalls
1

We found 9 models of iFuse TORQ Implant System by Si-Bone Inc. in the FDA's device registry (GUDID). Together they are named in 6 adverse event reports in the FDA's MAUDE database, received between Oct 21, 2021 and Jan 5, 2022 — classified as 6 injuries.

The most frequently reported specific device problem is “Malposition of Device” (4 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

iFuse TORQ Implant System recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

  1. Aug 21, 2026Open, Classified

    The pelvic fixation screws failed to meet acceptance criteria for tube packaging seal integrity testing; therefore, sterility assurance cannot be ensured.

    Z-0146-2027 · Root cause: Packaging · names 5 of these models · Recall details · FDA record ↗

Most reported iFuse TORQ Implant System problems

Device problems

  • Malposition of Device4
  • Adverse Event Without Identified Device or Use Problem1
  • Loss of Osseointegration1

Patient problems

  • Undesired Nerve Stimulation4
  • Arthralgia1
  • Cellulitis1

iFuse TORQ Implant System models

9 models, most reported first. Each model has its own page with its reports, recalls and device details.

Recent iFuse TORQ Implant System adverse event reports

The 6 most recent reports across all models, in the reporter's own words as published by the FDA.

Other Si-Bone Inc. products

All Si-Bone Inc. devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page