Exactech Optetrak Logic CC Stem Extension Recall: Non-conforming threads

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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 is recalling its Optetr:ak Logic CC Stem Extension (22mm x 160mm) because it may have non-conforming internal threads. This could lead to improper fitting during knee replacement surgery, potentially causing complications.

Why it’s dangerous

Non-conforming internal threads could cause improper alignment or fitting during knee replacement surgery. This might lead to complications such as improper joint function or increased risk of revision surgery.

Who’s affected

Patients scheduled for total knee replacement surgery using this specific stem extension are affected. Surgeons and medical facilities using the product are at risk of complications during procedures.

How to tell if you have this one

Check for the product name 'Optetrak Logic CC Stem Extension', size 22mm x 160mm, and serial number 5370045 on the packaging or documentation.

Brand
Exactech
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for the serial number 5370045 on the product packaging or documentation to confirm if it is affected.

✎ GovInfoNow

Questions people ask

What is the specific model of the recalled product?

The recalled product is the Optetrak Logic CC Stem Extension, 22mm x 160mm.

What is the serial number for the affected units?

The affected units have serial number 5370045.

Is there a remedy for this recall?

The recall record does not specify a remedy.

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-3209-2018 — Exactech Exactech

Hello,

I own a Exactech that is covered by recall Z-3209-2018 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-3209-2018 (May 8, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3209-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 21, 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 Optetrak Logic CC Stem Extension, 22mm x 160mm The OPTETRAK Logic CC Total Knee System is indicated for use in

Recall notice