Stryker GmbH recalls Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S.

Recall date

May 28, 2025

Source

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

Recall number

Z-1914-2025

FDA classification

Class II

Brand / firm

Stryker GmbH

Sold / distributed

Worldwide - US Nationwide distribution in the states of AL, FL, NJ, OR and the countries of Australia and Japan.

Why it was recalled

Investigation confirmed that the GAMMA4 Right Long Nail was manufactured with the geometry of a left nail.

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

What was recalled

Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S.