Reported Sep 28, 2016 · Terminated

FPS 35mm x 3.5 mm non-locking screw

Ortho Solutions Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Ortho Solutions Inc · 330 Franklin Tpke · Mahwah, NJ · 07430-3524

Is this the product you have?

  • FPS 35mm x 3.5 mm non-locking screw
Lot codes and dates
  • Part number - OS326835 Lot number10100/269A12-68051
Amount recalled
15

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Oct 12, 2016 · Data as of Sep 19, 6:00 PM UTC

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