FDA-Device2019-12-04Class II
Stratum Foot Plating System-NL LP Screw 3.5x50mm ST, sterile. Catalog Number: STRM-NL-3550ST - Product Usage: The 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.
Nextremity Solutions
Hazard
Product labeled as STRM-NL-3550ST, NL LP Screw 3.5x50mm ST, lot M1151 may contain the incorrect screw type and length
Sold states
US Nationwide distribution.
Affected count
49 units
Manufactured in
6210 N Buffalo St, Warsaw, IN, United States
Products
Stratum Foot Plating System-NL LP Screw 3.5x50mm ST, sterile. Catalog Number: STRM-NL-3550ST - Product Usage: The 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0534-2020Don't want to check this manually?
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