Lower risk Medical device recall · FDA · Published August 10, 2020

Exactech Vantage Ankle Implant Has Labeling Error - Recalled

Exactech recalls specific Vantage Total Ankle Tibial Insert models due to incorrect size labeling on the implant. The label shows size 3 but the actual size is 4. This may cause improper fitting. No action is required as the error is not dangerous.

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

🇺🇸 FDA recall #Z-2926-2020Medical device Exactech ›

Lower-risk recall

The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm, were found to have a labeling error. Exactech is recalling the Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm because they were found to have a labeling error. The upper right corner of the label incorrectly identifies the implant size as 3 when the implant size is 4.

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Contact the company

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

✎ GovInfoNow plain-language explainer

Exactech is recalling a specific ankle implant model due to a labeling error where the size is incorrectly listed as 3 instead of 4. This could lead to improper fitting if used without correction, but the error does not pose an immediate safety risk. Read more at govinfonow.com/recall/64505-exactech-vantage-ankle-implant-has-labeling-error-recalled.

Source Summary by GovInfoNow · govinfonow.com/recall/64505-exactech-vantage-ankle-implant-has-labeling-error-recalled · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2926-2020

Cite this page

“Exactech Vantage Ankle Implant Has Labeling Error - Recalled.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64505-exactech-vantage-ankle-implant-has-labeling-error-recalled. Based on FDA recall #Z-2926-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2926-2020%22&limit=1).

The FDA announced on Aug. 10, 2020, that Exactech, Inc. is recalling The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm due to a labeling error. The company initiated the voluntary Class II recall after discovering the implant size was incorrectly identified on the label.

How to tell if you have it

Brand: Exactech
Product: The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm
Catalog Number: 350-22-44
Lot numbers: 05144883 and 05144884
Serial Numbers: 6417984, 6417989, 6417996, 6417997, 6417998, 6418002, 6418003, 6488668, 6488673, 6488674, 6488675
Units affected: 11

The hazard

The upper right corner of the label incorrectly identifies the implant size as 3 when the actual implant size is 4. The FDA said this labeling error prompted the recall.

Context

GovInfoNow's records show Exactech, Inc. has had 34 other recalls on record since June 23, 2017. Other recent recalls of similar products include Equinoxe Core Instrument Kit Recall: Missing Cross-Pin Hazard (Feb. 3, 2026), Equinoxe Ergo Adjustable Angle rTSA Reamer 42mm: Design Update Required (Sept. 5, 2025), and Exactech Reverse Shoulder Humeral Liners Recall: Dimensional Specification Issue (Aug. 15, 2025).

How to tell if you have this one

Check the label on the implant for the size listed in the upper right corner. The recalled model has a label that says '3' but the actual size is 4. The specific lot numbers (05144883, 05144884) and serial numbers (6417984, 6417989, etc.) are listed in the recall notice.

Brand
Exactech
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Label
Verify the implant size on the label; the recalled model shows size 3 but is actually size 4.

Where it went and when

Where it was distributed

Distributed in 4 states, and outside the U.S.

FDA distribution: “Domestic: CO,FL,OK, PA. International: Chile” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Colorado, Florida, Oklahoma, Pennsylvania.

Recall timeline

FDA published this recall 30 days after the firm started it.

Aug 10, 2020Firm started the recall
Aug 31, 2020FDA classified it Class II
Sep 9, 2020Published in FDA’s Enforcement Report

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

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Link to this recall

<a href="https://govinfonow.com/recall/64505-exactech-vantage-ankle-implant-has-labeling-error-recalled">Exactech Vantage Ankle Implant Has Labeling Error - Recalled (GovInfoNow)</a>

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-2926-2020 (August 10, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2926-2020 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.