FDA-Device2015-07-01Class II

Cannula and Seal; 5mm x 100mm and 12mm x 100mm Model #: CTS02 and CTS22. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.

Stryker Sustainability Solutions
Hazard

Stryker Sustainability Solutions is recalling Trocars because they have received reports indicating that some may fracture at the distal tip resulting in fragments at the surgical site.

Sold states
Distributed Nationwide including Puerto Rico.
Affected count
147,351
Manufactured in
1810 W Drake Dr, Tempe, AZ, United States
Products
Cannula and Seal; 5mm x 100mm and 12mm x 100mm Model #: CTS02 and CTS22. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1836-2015

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