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U.S. Department of Health and Human Services

Class 2 Device Recall Percuvance(R) Percutaneous Shaft 36cm

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  Class 2 Device Recall Percuvance(R) Percutaneous Shaft 36cm see related information
Date Initiated by Firm January 03, 2018
Create Date January 18, 2019
Recall Status1 Terminated 3 on October 30, 2020
Recall Number Z-0754-2019
Recall Event ID 81909
510(K)Number K153063  
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
Product Percuvance(R) Percutaneous Shaft 36cm, PCVSHL3

The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate Intended Use: 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.
Code Information Batch/Lot Numbers: 73A1700535, 73B1600170, 73B1700073, 73B1700523, 73B1700646, 73C1600058, 73C1600706, 73D1600482, 73F1600086, 73G1600207, 73G1600468, 73G1600573, 73G1700041, 73G1700311, 73G1700577, 73H1600509, 73H1700513, 73H1700526, 73H1700531, 73H1700532, 73J1700100, 73J1700553, 73M1600016, 73M1600027, 73M1600231  
Recalling Firm/
Manufacturer		 Teleflex Medical
3015 Carrington Mill Blvd
Morrisville NC 27560-5437
For Additional Information Contact customer service
855-419-8507
Manufacturer Reason
for Recall		 There is potential for a piece of the distal tip on the Percuvance shaft to become deformed and possibly break off during use. If a piece did break off it could compromise the functionality and security of the tool tip. Should this occur during use, surgical intervention may be required.
FDA Determined
Cause 2		 Process control
Action The firm, Teleflex, sent an "Urgent Medical Device Recall" letter dated 1/3/2019 to its customers on 01/03/2019. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: 1.If you have affected stock in inventory, immediately discontinue use and quarantine the products. 2. Please complete the enclosed Recall Acknowledgement Form as soon as possible indicating whether you do or do not have stock and fax it to 1-855-419-8507 or email to recalls@teleflex.com or hand it to your sales representative. A customer service representative will contact you with a Return Goods Authorization (RGA) number and provide instructions for the return of products. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-396-2111.
Quantity in Commerce 1962 units
Distribution Worldwide Distribution: US (nationwide) and countries of: Australia, Belgium, China, Czech Republic, France, Germany, Great Britain, Iran, Ireland, Italy, Japan, Lebanon, Netherlands, Qatar, Romania, Saudi Arabia, Singapore, Spain, Taiwan, Turkey, and the United Arab Emirates.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = Teleflex Medical, Inc.
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