FDA-Device2016-09-28Class II

FPS 35mm x 3.5 mm non-locking screw

Ortho Solutions Inc
Hazard

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

Sold states
US Distribution
Affected count
15
Manufactured in
330 Franklin Tpke, Mahwah, NJ, United States
Products
FPS 35mm x 3.5 mm non-locking screw

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2835-2016

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