Z-0201-2018Class II

Vantage Total Ankle Tibial Insert, Fixed Bearing, 10 mm, Left, Size 3. Exactech Inc. Intended for patients...

Name: Z-0201-2018 Vantage Total Ankle Tibial Insert, Fixed Bearing, 10 mm, Left, Size 3. Exactech Inc. Intended for patients...
Creator: Exactech, Inc.
Published: 2017-05-16
License: https://open.fda.gov/license/

Exactech, Inc. / initiated 2017-05-16 / Terminated / root cause: labeling and UDI

FDA source

Exactech, Inc. began a recall of Vantage Total Ankle Tibial Insert, Fixed Bearing, 10 mm, Left, Size 3. Exactech Inc. Intended for patients with ankle joints damage by severe rheumatoid... on 2017-05-16. FDA classified it as Class II and gives the reason as "Possible inner labeling and packaged device not matching the outer label on the box". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0201-2018
Classification: Class II
Status: Terminated
Initiated: 2017-05-16
Posted: 2017-12-06
Terminated: 2021-04-22
Recalling firm: Exactech, Inc.
Product: Vantage Total Ankle Tibial Insert, Fixed Bearing, 10 mm, Left, Size 3. Exactech Inc. Intended for patients with ankle joints damage by severe rheumatoid, post-traumatic, or degenerative arthritis. It is also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present. Indicated for cemented use only.
Product code: HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Reason for recall: Possible inner labeling and packaged device not matching the outer label on the box.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: Customers were notified via letter dated May 16, 2017. Instructions included to immediately cease distribution of the affected products, identify and quarantine any devices in inventory, complete and return the Recall Inventory Response Form, notify customers if further distributed. For further questions, please call (352) 377-1140.
Quantity in commerce: 9
Distribution: Distributed in North Carolina
Product codes and lots: Catalog Number 350-21-43, Serial Range 4537323 - 4537331, Expiration August 2024

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0201-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0200-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-13	2017-12-06
Z-0201-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-13	2017-12-06

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)