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

Recall date

October 9, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0534-2020

FDA classification

Class II

Brand / firm

Nextremity Solutions

Sold / distributed

US Nationwide distribution.

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.