# SI-BONE, Inc. recall opens medical devices buyers to alternatives (2026-10-21)

**Switch Opportunity Score:** 40/100

| Field | Value |
|---|---|
| Recalling firm | SI-BONE, Inc. |
| Product | iFuse TORQ Implant System  Model/Catalog Number: 10055T(10x55mm), 10060T(10x60mm), 10065T(10x65mm), 10080T(10x55mm), 11580T(11.5x80mm) |
| Replacement market | Medical devices |
| Agency | FDA medical devices |
| Severity | medium |
| Hazard | The pelvic fixation screws failed to meet acceptance criteria for tube packaging seal integrity testing; therefore, sterility assurance cannot be ensured. |
| Recall date | 2026-10-21 |
| Switch angle | Buyers and retailers of the recalled medical devices need a compliant replacement; position your product on the specific hazard fixed, with documentation. |
| Original recall record | /report/fdapulse/z-0146-2027 |

## Why this score
- Medium severity.

Source: CPSC, NHTSA and FDA device recalls (via our recall feeds), mapped to replacement markets (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0146-2027%22). Last refreshed: 2026-11-04T15:17:38.587Z.
Built from official CPSC, NHTSA and FDA recall data; market mapping is our classification. Do not make claims about a competitor's recall beyond what the agency published, and follow advertising and comparative-claims rules. Not a consumer report and may not be used for FCRA purposes. Informational only; not legal, investment or procurement advice. Not affiliated with any agency or company listed.