Medical device recalls Moderate risk

Wright Medical Technology, Inc. recalls WRIGHT EVOLVE Proline Head, Size: +2, OD: 22mm, REF 496H222

Recall date
December 27, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1102-2020
FDA classification
Class II
Brand / firm
Wright Medical Technology, Inc.
Sold / distributed
US

Why it was recalled

Two lots of EVOLVE Modular Radial Head could have the wrong size product in the package. Both the label and laser marking are incorrect on the affected product.

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

What was recalled

WRIGHT EVOLVE Proline Head, Size: +2, OD: 22mm, REF 496H222

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