Exactech, Inc. recalls Tibial Alignment Guide, REF 351-10-00 Vantage Fixed Ankle system components for ankle replacements.

Recall date

July 13, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2966-2018

FDA classification

Class II

Brand / firm

Exactech, Inc.

Sold / distributed

CA, OH, NY, OK, FL, TX, SC, Germany, Spain, Switzerland, and UK

Why it was recalled

Exactech is recalling the Tibial Alignment Guide because the Global Trade Item Number (GTIN) on the device is incorrect. The GTIN on the device reads 10885862525629, when it should read 10885862525628.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Tibial Alignment Guide, REF 351-10-00 Vantage Fixed Ankle system components for ankle replacements.