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Open, Classified

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

FDA Recall Z-2926-2020 · Posted None

Recalling FirmExactech, Inc.
Recall StatusOpen, Classified
Product CodeHSN
Date Initiated2020-08-10
Product Quantity11 units

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.

Firm 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].

Root Cause

Error in labeling

Distribution Pattern

Domestic: CO,FL,OK, PA. International: Chile

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K152217Exactech Vantage Total Ankle SystemExactech, Inc. · 2016-03-10

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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