Stryker 1 recalled over labeling errors

Recall date

March 29, 2024

Source

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

Official notice title

Stryker Leibinger GmbH & Co. KG recalls Stryker 1,5/1,7MM DYNAMIC MESH- STD-MEDIUM-Intended for the reconstruction, stabilization and rigid fixation of the bon…

Recall number

Z-1785-2024

FDA classification

Class II

Brand / firm

Stryker Leibinger GmbH & Co. KG

Sold / distributed

Nationwide

Why it was recalled

Mislabeled: Product labeled 56-90614 (90x90 Gold Mesh), was actually 56-90314 (90x90 Blue Mesh), may cause a delay in procedure

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

What was recalled

Stryker 1,5/1,7MM DYNAMIC MESH- STD-MEDIUM-Intended for the reconstruction, stabilization and rigid fixation of the bony areas of the cranial skeleton. Catalog Number: 56-90614