Stryker UniVise Spinous Process Fixation Plate System Inserter recalled over sterility concerns

Recall date

September 8, 2015

Source

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

Official notice title

Stryker Spine recalls Stryker UniVise Spinous Process Fixation Plate System Inserter, Stryker Spine, Non-Sterile. Reference Number 48590100.…

Recall number

Z-0222-2016

FDA classification

Class II

Brand / firm

Stryker Spine

Sold / distributed

Nationwide Distribution.

Why it was recalled

The Inserter Inner Shaft would not fit through the Inserter. The inner diameter of the cannulated shaft of the inserter was undersized.

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 UniVise Spinous Process Fixation Plate System Inserter, Stryker Spine, Non-Sterile. Reference Number 48590100. Manual Surgical Instrument.