Innovasis Excella II Screws Risk Breakage in Spinal Surgery

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Recalling firmInnovasis, Inc614 E 3900 S, N/A · Salt Lake City, UT 84107-1902

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✎ GovInfoNow plain-language explainer

What happened, in plain English

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.

Why it’s dangerous

The screws are at risk of breaking during spinal fusion procedures. If a screw breaks while stabilizing the spine, it could cause complications like instability or additional surgery.

Who’s affected

Skeletally mature patients undergoing spinal fusion surgery who received the recalled screws. Surgeons and medical staff using these screws are also affected.

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

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

✎ GovInfoNow

Questions people ask

Are these screws used in spinal surgery?

Yes, these screws are used as part of a pedicle screw system for spinal fusion in skeletally mature patients.

What happens if the screws break?

If the screws break during spinal fusion, they could cause instability or require additional surgery.

How can I check if I have the recalled screws?

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

Take action

Contact Innovasis

We’ve drafted a message you can send Innovasis to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-0644-2018 — Innovasis Innovasis

Hello,

I own a Innovasis that is covered by recall Z-0644-2018 from Innovasis.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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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.

Innovasis, Inc recalls Excella II Polyaxial Pedicle Screw used as a pedicle screw system in skeletally mature patients, is intended to provide

Lower-risk recall