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Unrated Medical device recall · FDA · Published August 21, 2026

iFuse TORQ Implant System: Pelvic Fixation Screws May Not Be Sterile

SI-BONE recalls 100 units of iFuse TORQ Implant System with specific model numbers and lots due to potential sterility issues from packaging seal failures.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0146-2027Medical deviceSI-BONE ›
✎ GovInfoNow plain-language explainer

SI-BONE is recalling 100 units of iFuse TORQ Implant System models 10055T, 10060T, 10065T, 10080T, and 11580T. The recall is because the pelvic fixation screws might not be sterile due to packaging seal failures. Read more at govinfonow.com/recall/1764833-si-bone-inc-recalls-ifuse-torq-implant-system-model-catalog.

Source Summary by GovInfoNow · govinfonow.com/recall/1764833-si-bone-inc-recalls-ifuse-torq-implant-system-model-catalog · Published October 27, 2026 · Updated October 27, 2026 · FDA enforcement record: FDA #Z-0146-2027

Cite this page

“iFuse TORQ Implant System: Pelvic Fixation Screws May Not Be Sterile.” GovInfoNow, updated October 27, 2026. https://govinfonow.com/recall/1764833-si-bone-inc-recalls-ifuse-torq-implant-system-model-catalog. Based on FDA recall #Z-0146-2027 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0146-2027%22&limit=1).

The FDA announced on Aug. 21, 2026, that SI-BONE, Inc. is voluntarily recalling its iFuse TORQ Implant System due to sterility risks. The agency stated the pelvic fixation screws failed packaging seal integrity testing, meaning sterility assurance cannot be ensured.

How to tell if you have it

  • Brand: SI-BONE
  • Product: iFuse TORQ Implant System
  • Model/Catalog Numbers: 10055T(10x55mm), 10060T(10x60mm), 10065T(10x65mm), 10080T(10x55mm), 11580T(11.5x80mm)
  • Lot Codes: 9142871, 9137761, 9139213, 9137781, 9142911
  • Units Affected: 100 units
  • Distribution: US Nationwide in FL, GA, HI, NC, OH, PA, SD, TX, VA

The hazard

According to the FDA, the pelvic fixation screws failed acceptance criteria for tube packaging seal integrity testing. Consequently, sterility assurance cannot be ensured for these devices.

Context

GovInfoNow's records show other recent recalls of similar products include Depuy ATTUNE Revision Hinge Femoral RT SZ 4 CEM (2026-04-03), Depuy ATTUNE Revision Hinge Femoral LT SZ 8 CEM (2026-04-03), and U2 Total Knee System PSA Box Trial (2026-05-20).

How to tell if you have this one

Check for model numbers 10055T(10x55mm), 10060T(10x60mm), 10065T(10x65mm), 10080T(10x55mm), or 11580T(11.5x80mm) on the implant packaging. The recall includes specific lot numbers: 9142871, 9137761, 9139213, 9137781, and 9142911.

  • Brand
    SI-BONE
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Identify the model number and lot number on the implant packaging to confirm if it is recalled.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 9 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: nationwideMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: named in the noticeSDIowa: nationwideIAIndiana: nationwideINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: nationwideCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: named in the noticeVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: named in the noticeNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: named in the noticeGAHawaii: named in the noticeHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “US Nationwide distribution in the states of FL, GA, HI, NC, OH, PA, SD, TX, VA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Florida, Georgia, Hawaii, North Carolina, Ohio, Pennsylvania, South Dakota, Texas, Virginia.

Recall timeline

FDA published this recall 2 months after the firm started it.

1. Firm started the recall: Aug 21, 202612. FDA classified it Class II: Oct 9, 202623. Published in FDA’s Enforcement Report: Oct 21, 202634. Added to GovInfoNow: Oct 27, 202642026
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. Added to GovInfoNow

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Where were these implants distributed?

The implants were distributed nationwide in the states of FL, GA, HI, NC, OH, PA, SD, TX, and VA.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0146-2027 (August 21, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0146-2027 to see it in context.
  • Plain-language summary written by qwen3:4b on October 27, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA