Recall Z-0146-2027— SI-BONE, Inc.

Name: FDA recall Z-0146-2027
Creator: U.S. Food and Drug Administration
Published: 2026-08-21

Class II · Ongoing

Class II FDA medical device recall by SI-BONE, Inc., initiated 2026-08-21. It names one FDA 510(k) clearance: K203247. Product: iFuse TORQ Implant System Model/Catalog Number: 10055T(10x55mm), 10060T(10x60mm), 10065T(10x65mm), 10080T(10x55mm), 11580T(11.5x80mm). Reason: The pelvic fixation screws failed to meet acceptance criteria for tube packaging seal integrity testing; therefore, sterility assurance cannot be ensured..

Recalling firm: SI-BONE, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2026-08-21
Firm location: Santa Clara, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K203247 — iFuse-TORQ Implant SystemSI-BONE, Inc.·cleared 2021-02-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

iFuse TORQ Implant System Model/Catalog Number: 10055T(10x55mm), 10060T(10x60mm), 10065T(10x65mm), 10080T(10x55mm), 11580T(11.5x80mm)

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.