iFuse TORQ Implant System Model/Catalog Number: 10055T(10x55mm), 10060T(10x60mm), 10065T(10x65mm), 10080T(10x55mm), 115
Summary
The FDA issued a Class II for iFuse TORQ Implant System Model/Catalog Number: 10055T(10x55mm), 10060T(10x60mm by SI-BONE, Inc.. Reason: The pelvic fixation screws failed to meet acceptance criteria for tube packaging seal integrity testing; therefore, sterility assurance cannot be ensu.
Details
Source
Device Recall
External ID
Z-0146-2027
Action Date
2026-10-21
Status
Ongoing
Category
device
Product Description
iFuse TORQ Implant System Model/Catalog Number: 10055T(10x55mm), 10060T(10x60mm), 10065T(10x65mm), 10080T(10x55mm), 11580T(11.5x80mm)
Lot/Code Info: 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
Quantity Affected: 100 units
Reason for Recall
The pelvic fixation screws failed to meet acceptance criteria for tube packaging seal integrity testing; therefore, sterility assurance cannot be ensured.
Distribution
US Nationwide distribution in the states of FL, GA, HI, NC, OH, PA, SD, TX, VA.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-08-21
Company
Santa Clara, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 150 device recalls issued in the same week, part of 446 device-related FDA actions this month.
SI-BONE, Inc. has 13 FDA actions in our database, including 1 recall and 12 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (SI-BONE, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does SI-BONE, Inc. have FDA actions?
SI-BONE, Inc. has 13 FDA actions in our database, including 1 recall and 12 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0146-2027" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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