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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