Medical device recalls Moderate risk

Oscor Inc. recalls Destino Twist 14F (also branded as Guidestar 14F)

Recall date
December 22, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0646-2022
FDA classification
Class II
Brand / firm
Oscor Inc.
Sold / distributed
Distribution to TN and PA in USA OUS distribution to Czech Republic

Why it was recalled

There is potential for separation between the threaded hub and threaded cap at the proximal end of the device.

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

What was recalled

Destino Twist 14F (also branded as Guidestar 14F)

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