Stryker Sustainability Solutions recalls Fios First Entry; 5mm x 100mm and 12mm x 100mm; Model #:CTF03 and CTF73. Indicated for use to establish a port of ent

Recalled July 1, 2015 · FDA recall Z-1834-2015 · 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. · FDA Class II

Units

147,351

Sold at

Distributed Nationwide including Puerto Rico.

Description

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.

Product

Fios First Entry; 5mm x 100mm and 12mm x 100mm; Model #:CTF03 and CTF73. 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.

Manufacturer(s)

Stryker Sustainability Solutions

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →