Medical device recalls Moderate risk

Stryker Howmedica Osteonics Corp. recalls Radio-Capitellum, Capitellum, Left, Large, Do Not Reuse, Rx Only. Indicated for use in the elbow for reduction or relie…

Recall date
June 24, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2428-2015
FDA classification
Class II
Brand / firm
Stryker Howmedica Osteonics Corp.
Sold / distributed
Worldwide Distribution.

Why it was recalled

Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging integrity (sterile barrier) of the packaging type KIT I may potentially be compromised by transportation.

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

What was recalled

Radio-Capitellum, Capitellum, Left, Large, Do Not Reuse, Rx Only. Indicated for use in the elbow for reduction or relief of pain and/or improved elbow function in skeletally mature patients.

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