Exactech Equinoxe Platform Fracture Stem Recall: Incorrect Laser Marking Risk

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

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Exactech is recalling 6.5mm right Equinoxe Platform Fracture Stems that may be incorrectly laser marked as right when they should be left. This could cause improper use during medical procedures.

Why it’s dangerous

The stem may be marked as a right stem when it should be a left stem. This could lead to improper use during spinal fusion procedures if the wrong stem is implanted.

Who’s affected

Orthopedic surgeons and medical professionals who use these stems for spinal procedures. Patients receiving these implants are at risk if the wrong stem is used.

How to tell if you have this one

Check for the product name 'Equinoxe Platform Fracture Stem, 6.5mm, Right' with serial numbers 4971292-4971303. The device is intended for cemented use only.

Brand
Exactech
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Serial Number
Verify the serial number is within 4971292-4971303 to confirm if it's affected.

✎ GovInfoNow

Questions people ask

Why is this recall happening?

The device may be incorrectly laser marked as a right stem when it should have been marked as a left stem.

What is the risk of using this product?

Incorrect marking could lead to improper use during spinal fusion procedures if the wrong stem is implanted.

How can I check if my product is affected?

Check the serial number on the product; affected units have serial numbers 4971292-4971303.

Take action

Contact Exactech

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

✉️ Open in email

Subject: Recall Z-0308-2021 — Exactech Exactech

Hello,

I own a Exactech that is covered by recall Z-0308-2021 from Exactech.

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-0308-2021 (September 25, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0308-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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 Equinoxe Platform Fracture Stem, 6.5mm, Right - Product Usage: The Equinoxe Platform Fracture Stem is indicated for

Lower-risk recall