FDA-Device2016-12-21Class II
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.
Stryker Sustainability Solutions
Hazard
An increase in reports indicating that the reprocessed H12LP Trocar adjustable plug may break in the packaging or during use.
Sold states
Worldwide Distribution - US (nationwide) and Internationally to Israel and Canada Foreign distribution to the following; IL and CA
Affected count
40,476 devices
Manufactured in
1810 W Drake Dr, Tempe, AZ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0765-2017Don't want to check this manually?
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