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Stryker Sustainability Solutions recalls Reprocessed Xcel Bladeless Trocar (H12LP) Model # H12LP Reprocessed Endoscopic Trocars are indicated for use to establ
Recalled December 21, 2016 · FDA recall Z-0765-2017 · Stryker Sustainability Solutions
Hazard
An increase in reports indicating that the reprocessed H12LP Trocar adjustable plug may break in the packaging or during use. · FDA Class II
Units
40,476 devices
Sold at
Worldwide Distribution - US (nationwide) and Internationally to Israel and Canada Foreign distribution to the following; IL and CA
Description
An increase in reports indicating that the reprocessed H12LP Trocar adjustable plug may break in the packaging or during use.
Product
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.
Manufacturer(s)
Stryker Sustainability Solutions
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →