Medical device recalls Moderate risk

Stryker GmbH recalls Femoral Nail, RIGHT T2 GTN ¿14x460 mm, Product Number 18511446S

Recall date
April 27, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2406-2018
FDA classification
Class II
Brand / firm
Stryker GmbH
Sold / distributed
The products were distributed to the following US states: AL, Co, FL, KY, NC, TN, UT, and WA.

Why it was recalled

The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage.

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

What was recalled

Femoral Nail, RIGHT T2 GTN ¿14x460 mm, Product Number 18511446S

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