Recall Z-3219-2017— Teleflex Medical

Name: FDA recall Z-3219-2017
Creator: U.S. Food and Drug Administration
Published: 2017-07-19

Class II · Terminated

Class II FDA medical device recall by Teleflex Medical, initiated 2017-07-19, terminated 2020-10-06. It names one FDA 510(k) clearance: K153063. Product: Percuvance Gripper Grasper Tool Tip The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate soft tissue to access certain areas of the abdomen. The system is used to grasp, manipulate, cut, cauterize and deliver Hem-o-lok ligating clips to soft tissue during laparoscopic surgery.. Reason: For some of the recalled products, the security of the connection between the shaft and the tool tip may be compromised. For certain other recalled lots of the products, the jaws of the tool tips may close abruptly..

Recalling firm: Teleflex Medical
Classification: Class II
Status: Terminated
Initiated: 2017-07-19
Terminated: 2020-10-06
Firm location: Morrisville, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K153063 — PERCUVANCE PERCUTANEOUS SURGICAL SYSTEMTeleflexmedical, Inc.·cleared 2016-04-08

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

Percuvance Gripper Grasper Tool Tip The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate soft tissue to access certain areas of the abdomen. The system is used to grasp, manipulate, cut, cauterize and deliver Hem-o-lok ligating clips to soft tissue during laparoscopic surgery.

Reason for recall

For some of the recalled products, the security of the connection between the shaft and the tool tip may be compromised. For certain other recalled lots of the products, the jaws of the tool tips may close abruptly.

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