Medical device recalls Moderate risk

Nextremity Solutions recalls Stratum MDS Screw 3.5x46mm ST Part Number: STRM-MDS-3546ST

Recall date
November 11, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0776-2020
FDA classification
Class II
Brand / firm
Nextremity Solutions
Sold / distributed
Nationwide

Why it was recalled

Components 2mm shorter than indicated on the package label

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 MDS Screw 3.5x46mm ST Part Number: STRM-MDS-3546ST

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