Stryker Sustainability Solutions recalls Reprocessed Xcel Bladeless Trocar (H12LP) Model # H12LP Reprocessed Endoscopic Trocars are indicated for use to establi…

Recall date

November 11, 2016

Source

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

Recall number

Z-0765-2017

FDA classification

Class II

Brand / firm

Stryker Sustainability Solutions

Sold / distributed

Worldwide Distribution - US (nationwide) and Internationally to Israel and Canada Foreign distribution to the following; IL and CA

Why it was recalled

An increase in reports indicating that the reprocessed H12LP Trocar adjustable plug may break in the packaging or during use.

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

What was recalled

Reprocessed Xcel Bladeless Trocar (H12LP) Model # H12LP Reprocessed Endoscopic Trocars are indicated for use to establish a port of entry for endoscopic instruments in patients requiring minimally invasive surgical procedures.