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Lower risk Medical device recall · FDA · Published January 8, 2018

Innovasis Excella II Screws Risk Breakage in Spinal Surgery

Innovasis recalls 9 lots of 8.5mm Polyaxial Pedicle Screws used in spinal fusion that may break during surgery, causing potential complications.

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

🇺🇸 FDA recall #Z-0644-2018Medical deviceInnovasis ›
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Contact the company

Recalling firmInnovasis, Inc614 E 3900 S · Salt Lake City, UT 84107-1902
✎ GovInfoNow plain-language explainer

Innovasis is recalling specific lots of 8.5mm Polyaxial Pedicle Screws used in spinal surgery that could break during use. This breakage risk could lead to complications if the screws fail while stabilizing the spine. Read more at govinfonow.com/recall/72160-innovasis-excella-ii-screws-risk-breakage-in-spinal-surgery.

Source Summary by GovInfoNow · govinfonow.com/recall/72160-innovasis-excella-ii-screws-risk-breakage-in-spinal-surgery · Updated August 31, 2026 · FDA enforcement record: FDA #Z-0644-2018

Cite this page

“Innovasis Excella II Screws Risk Breakage in Spinal Surgery.” GovInfoNow, updated August 31, 2026. https://govinfonow.com/recall/72160-innovasis-excella-ii-screws-risk-breakage-in-spinal-surgery. Based on FDA recall #Z-0644-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0644-2018%22&limit=1).

Innovasis, Inc recalled Excella II Polyaxial Pedicle Screws on Jan. 8, 2018, according to the FDA. Nine lots of 8.5 mm screws are at risk of breakage.

How to tell if you have it

  • Brand: Innovasis
  • Product: Excella II Polyaxial Pedicle Screw
  • Catalog/Part No.: E2S8530, E2S8535, E2S8540, E2S8545, E2S8550, E2S8555, E2S8560 with Lot Number: 1101
  • Catalog/Part No.: E28540, E28545 with Lot Number: 1201
  • Quantity: 1,010 parts
  • Distribution: United States

The hazard

Nine lots of 8.5 mm Polyaxial Pedicle Screws are at risk of breakage.

Context

GovInfoNow's records show Innovasis, Inc has had three other recalls since April 7, 2020. Other recent recalls of similar products include the Innovasis Anti-Torque Vector Pedicle Screw LS-749 Recall on May 22, 2026, and the Innovasis TxHA PEEK IBF System Recall on Aug. 14, 2024.

How to tell if you have this one

Check for part numbers E2S8530-E2S8560 or E28540-E28545 with lot numbers 1101 or 1201. Each screw has engraved part number and lot number.

  • Brand
    Innovasis
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Screw Details

    Look for engraved part numbers E2S8530-E2S8560 or E28540-E28545 with lot numbers 1101 or 1201.

How this recall unfolded

Recall timeline

FDA terminated this recall 50 days after the firm started it.

1. Firm started the recall: Jan 8, 201812. FDA classified it Class II: Feb 20, 201823. FDA terminated the recall: Feb 27, 201834. Published in FDA’s Enforcement Report: Feb 28, 201842018
  1. Firm started the recall
  2. FDA classified it Class II
  3. FDA terminated the recall
  4. Published in FDA’s Enforcement Report

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

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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-0644-2018 (January 8, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0644-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on August 31, 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