Z-0146-2027

iFuse TORQ Implant System Model/Catalog Number: 10055T(10x55mm), 10060T(10x60mm), 10065T(10x65mm)...

Name: Z-0146-2027 iFuse TORQ Implant System Model/Catalog Number: 10055T(10x55mm), 10060T(10x60mm), 10065T(10x65mm)...
Creator: SI-BONE, Inc.
Published: 2026-08-21
License: https://open.fda.gov/license/

SI-BONE, Inc. / initiated 2026-08-21 / Open, Classified

FDA source

Recall record

Recall number: Z-0146-2027
Status: Open, Classified
Initiated: 2026-08-21
Posted: 2026-10-09
Recalling firm: SI-BONE, Inc.
Product: iFuse TORQ Implant System Model/Catalog Number: 10055T(10x55mm), 10060T(10x60mm), 10065T(10x65mm), 10080T(10x55mm), 11580T(11.5x80mm)
Product code: OUR Sacroiliac Joint Fixation
Reason for recall: The pelvic fixation screws failed to meet acceptance criteria for tube packaging seal integrity testing; therefore, sterility assurance cannot be ensured.
FDA root cause: Packaging
Action: On August 31, 2026 and September 2, 2026, SI-Bone, Inc. Chief Medical Officer spoke with affected surgeons via phone concerning the recall.
Quantity in commerce: 100 units
Distribution: US Nationwide distribution in the states of FL, GA, HI, NC, OH, PA, SD, TX, VA.
Product codes and lots: 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

Product code OUR

K203247Class IIiFuse-TORQ™ Implant SystemSI-BONE, Inc. / cleared 2021-02-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-10-13. View this recall on fda.gov (opens on fda.gov)