RecallReported October 21, 2026
Class II recall by SI-BONE, Inc.
iFuse TORQ Implant System Model/Catalog Number: 10055T(10x55mm), 10060T(10x60mm), 10065T(10x65mm), 10080T(10x55mm), 11580T(11.5x80mm)
FDA's enforcement report of October 21, 2026 lists a Class II recall by SI-BONE, Inc. of Santa Clara, CA. Product: iFuse TORQ Implant System Model/Catalog Number: 10055T(10x55mm), 10060T(10x60mm), 10065T(10x65mm), 10080T(10x55mm), 11580T(11.5x80mm). Status: Ongoing.
On the record
- Recalling firm
- SI-BONE, Inc.
- Location
- Santa Clara, CA
- Classification
- Class II
- Status
- Ongoing
- Recall number
- Z-0146-2027
- Product type
- Devices
- Recall initiated
- 2026-08-21
- Reported by FDA
- 2026-10-21
The full record
An account shows the reason for the recall, where the product was distributed and the lots.
What a recall is
FDA classifies a recall by the hazard. Class I: a reasonable probability that the product will cause serious adverse health consequences or death. Class II: the product may cause temporary or medically reversible harm, or the probability of serious harm is remote. Class III: the product is not likely to cause adverse health consequences.
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From FDA enforcement reports. The record may have changed since it was read.
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