Z-2926-2020Class II

The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm

Name: Z-2926-2020 The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm
Creator: Exactech, Inc.
Published: 2020-08-10
License: https://open.fda.gov/license/

Exactech, Inc. / initiated 2020-08-10 / Open, Classified / root cause: labeling and UDI

FDA source

Exactech, Inc. began a recall of The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm on 2020-08-10. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2926-2020
Classification: Class II
Status: Open, Classified
Initiated: 2020-08-10
Posted: 2020-08-31
Recalling firm: Exactech, Inc.
Product: The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm.
Product code: HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Reason for 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.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: On August 18, 2020 Exactech sent an Urgent Product Recall Notice to all its consignees with the following instructions: -Immediately cease distribution or use of this product. -Extend this information to your accounts that may have this product in their possession. - Identify and quarantine any of the subject devices in your inventory (including loaner kits). -Complete and returned the attached Recall Inventory Response Form to Exactech via email at [email protected].
Quantity in commerce: 11 units
Distribution: Domestic: CO,FL,OK, PA. International: Chile
Product codes and lots: Catalog Number: 350-22-44 Lot numbers: 05144883 and 05144884 Serial Numbers: 6417984, 6417989, 6417996, 6417997, 6417998, 6418002, 6418003, 6488668, 6488673,6488674,6488675.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2926-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2926-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-09-09	2020-08-31

Product code HSN

K152217Class IIExactech Vantage Total Ankle SystemExactech, Inc. / cleared 2016-03-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)