Reported Dec 4, 2019 · Terminated

Stratum Foot Plating System-NL LP Screw 3.5x50mm ST, sterile. Catalog Number: STRM-NL-3550ST - Product Usage: The…

Nextremity Solutions

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: Nextremity Solutions · 6210 N Buffalo St · Warsaw, IN · 46580

Is this the product you have?

  • Stratum Foot Plating System-NL LP Screw 3.5x50mm ST, sterile
  • Catalog NumberSTRM-NL-3550ST -
  • Product UsageThe Stratum Foot Plating System is a plate and screws construct indicated for fixation of fractures, osteotomies, nonunions, malunions and fusions of small bones and small bone segments, particularly in osteopenic bone
Lot codes and dates
  • Lot NumberM1151
  • UDI00817701022558
Amount recalled
49 units

Where it was sold

  • Nationwide

Why it was recalled

Product labeled as STRM-NL-3550ST, NL LP Screw 3.5x50mm ST, lot M1151 may contain the incorrect screw type and length

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 Jun 24, 2020 · Data as of Sep 19, 5:31 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.