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 entry…

Recall date

June 1, 2015

Source

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

Recall number

Z-1834-2015

FDA classification

Class II

Brand / firm

Stryker Sustainability Solutions

Sold / distributed

Distributed Nationwide including Puerto Rico.

Why it was recalled

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.

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

What was recalled

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.