Medical device recalls Moderate risk

Ortho Solutions product recalled over labeling errors

Recall date
July 21, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Ortho Solutions Inc recalls FPS 35mm x 3.5 mm non-locking screw
Recall number
Z-2835-2016
FDA classification
Class II
Brand / firm
Ortho Solutions Inc
Sold / distributed
US Distribution

Why it was recalled

Mislabeling of a single batch of FPS 3.5 x 35 mm Locking Screw as being Non-Locking Screws.

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

What was recalled

FPS 35mm x 3.5 mm non-locking screw

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