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U.S. Department of Health and Human Services

Class 2 Device Recall Horizon 24 Large Titanium Clips with Adhesive Backing

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  Class 2 Device Recall Horizon 24 Large Titanium Clips with Adhesive Backing see related information
Date Initiated by Firm August 08, 2013
Create Date August 03, 2016
Recall Status1 Terminated 3 on August 15, 2016
Recall Number Z-2327-2016
Recall Event ID 74669
510(K)Number K982313  
Product Classification Clip, implantable - Product Code FZP
Product Horizon 24 Large Titanium Clips with Adhesive Backing, Ref 004204, Rx Only, Sterile.

The metal ligating clips are intended for use in procedures involving vessels or anatomic structures for which the surgeon determines ligating clips are the best choice. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable
Code Information Lot/Serial Number 01J1200435
Recalling Firm/
Manufacturer		 Teleflex Medical
3015 Carrington Mill Blvd
Morrisville NC 27560-5437
For Additional Information Contact Alice K. Harper
610-378-0131
Manufacturer Reason
for Recall		 The manufacturing and expiration dates are not printed on the blister pack label.
FDA Determined
Cause 2		 Error in labeling
Action Teleflex sent an Urgent Medical Device Recall Notification dated August 8, 2013, to all affected customers. The letter requested that they quarantine the product and to return it to Teleflex. An acknowledgment form was included with the letter which also was to be returned to Teleflex. A separate letter was sent to distributors requesting they conduct a sub-recall. If you have any further questions, please call (610) 378-0131.
Quantity in Commerce 8,220 ea.
Distribution USA Distribution to the states of :AL, AZ, CA, CT, FL, IL, KY, MD, MI, MN, NM, NY, NC, OR, PA, SC, TX, VA, WA, WI, and Internationally to Canada
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 = FZP and Original Applicant = WECK CLOSURE SYSTEMS
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