Recall Z-2533-2017— Applied Medical Resources Corp

Name: FDA recall Z-2533-2017
Creator: U.S. Food and Drug Administration
Published: 2017-05-04

Class II · Terminated

Class II FDA medical device recall by Applied Medical Resources Corp, initiated 2017-05-04, terminated 2018-03-06. It names 2 FDA 510(k) clearances: K072674, K060096. Product: Kii Shielded Bladed trocars (CTB14), Kii Low profile trocars (CTB23), and Kii 5x55mm Optical Z-Thread Dual Pack (CTR14) trocars.. Reason: Due to possibility of insufficient sterilization..

Recalling firm: Applied Medical Resources Corp
Classification: Class II
Status: Terminated
Initiated: 2017-05-04
Terminated: 2018-03-06
Firm location: Rancho Santa Margarita, CA, United States

510(k) clearances named in this recall

2 on FDA's record

K072674 — KII TROCAR SYSTEMApplied Medical Resources Corp.·cleared 2007-10-05
K060096 — MODULAR TROCAR SYSTEMApplied Medical Resources Corp.·cleared 2006-01-24

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

Kii Shielded Bladed trocars (CTB14), Kii Low profile trocars (CTB23), and Kii 5x55mm Optical Z-Thread Dual Pack (CTR14) trocars.

Reason for recall

Due to possibility of insufficient sterilization.

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