Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1835-2015 — Optical Access System; 5mm x 100mm and 12mm x 100mm; Model #: CTR03 and CTR73. 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.

U.S. FDA — Device Enforcement · United States · 2015-06-01 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1835-2015
Date of alert
2015-06-01
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Stryker Sustainability Solutions
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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