Recall Z-1834-2015— Stryker Sustainability Solutions

Name: FDA recall Z-1834-2015
Creator: U.S. Food and Drug Administration
Published: 2015-06-01

Class II · Terminated

Class II FDA medical device recall by Stryker Sustainability Solutions, initiated 2015-06-01, terminated 2016-08-16. It names one FDA 510(k) clearance: K063788. 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.. Reason: 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..

Recalling firm: Stryker Sustainability Solutions
Classification: Class II
Status: Terminated
Initiated: 2015-06-01
Terminated: 2016-08-16
Firm location: Tempe, AZ, United States

510(k) clearances named in this recall

1 on FDA's record

K063788 — REPROCESSED ENDOSCOPIC TROCARS AND CANNULASAscent Healthcare Solutions·cleared 2007-10-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.