Equinoxe Ergo Ergo Modular Impactor Handle Recall: Missing Cross-Pin Hazard

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Contact the company & request your remedy

Recalling firmExactech, Inc.2320 Nw 66th Ct, N/A · Gainesville, FL 32653-1630

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Exactech recalls Equinoxe Ergo Ergo Modular Impactor Handles with model number 321-09-05 because the impact handle may have a missing cross-pin. This could cause the tool to fail during use, potentially leading to injury.

Why it’s dangerous

The impact handle may have a missing cross-pin, which can cause the tool to become unstable or fail during use. This could lead to the tool slipping or breaking, potentially causing injury to the user.

Who’s affected

Users of the Equinoxe Ergo Ergo Modular Impactor Handle with model 321-09-05 are affected. Workers using this tool for impact tasks are most at risk if the cross-pin is missing.

How to tell if you have this one

Check for the model number 321-09-05 on the handle. All units with this model number are affected, as indicated by the lot code and part number.

Brand
Equinoxe Ergo
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check for Missing Cross-Pin
Inspect the impact handle for a missing cross-pin. If found, stop using the handle immediately.

✎ GovInfoNow

Questions people ask

Is this recall affecting all units of the product?

Yes, all units with model number 321-09-05 are affected.

What should I do if I have this product?

Check for a missing cross-pin. If found, stop using the handle immediately.

How can I get a replacement or repair?

The recall record does not specify a remedy or replacement process.

Take action

Contact Equinoxe Ergo

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

✉️ Open in email

Subject: Recall Z-1509-2026 — Equinoxe Ergo Equinoxe Ergo

Hello,

I own a Equinoxe Ergo that is covered by recall Z-1509-2026 from Equinoxe Ergo.

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-1509-2026 (February 3, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1509-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 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.

Exactech, Inc. recalls Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05

Lower-risk recall