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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