Medical device recalls Moderate risk

Stryker Howmedica Osteonics Corp. recalls Stryker, T2 Guidewire, Ball-Tipped, 3 x 1000mm Product Usage: Intended for the temporary stabilization of bone segments…

Recall date
January 21, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0878-2016
FDA classification
Class II
Brand / firm
Stryker Howmedica Osteonics Corp.
Sold / distributed
US Nationwide Distribution

Why it was recalled

During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.

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

What was recalled

Stryker, T2 Guidewire, Ball-Tipped, 3 x 1000mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.

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