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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm October 17, 2018
Create Date December 07, 2018
Recall Status1 Terminated 3 on April 10, 2020
Recall Number Z-0578-2019
Recall Event ID 81519
510(K)Number K050738  
Product Classification Powered Laser Surgical Instrument - Product Code GEX
Product Laser Fiber Assy-Single Use-LFS-365-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-
Private label: SU-365-RT SmartScope Packaging.


The Laser peripherals bare laser fibers, ENT fibers and Endoprobes are intended for use in laser surgical procedure for cutting, coagulating, or vaporizing in any soft tissue application for which compatible Nd: YAG, Ho: YAG, KTP and Diode lasers have been cleared.
Code Information 096875 00816901020272
Recalling Firm/
Manufacturer		 Leoni Fiber Optics GmbH
Muhldamm 6
Neuhaus-Schierschnitz Germany
For Additional Information Contact Recall contact
757-3673378
Manufacturer Reason
for Recall		 A percentage of the products shipped in Smartscope single-box packaging may exhibit a broken package seal, thus having compromised sterility. There have been two reports of compromised sterility; however, all products packaged in Smartscope single-box packaging are at risk of a compromised product seal. Broken seal pouches compromise sterility and could increase the risk of infection if used.
FDA Determined
Cause 2		 Packaging
Action The firm, LEONI, notified its distributor of the product issue on 10/16/18 via phone call and a subsequent "URGENT: MEDICAL DEVICE RECALL" letter. The distributor was informed of the product issue, and asked to disseminate recall information to customers. Actions to be taken by the Customer/User: End users should discontinue usage of the product. Product should be immediately quarantined. The Distributor should complete the acknowledgement of receipt form, to arrange for replacement and or credit to their account. A Leoni Customer Service Representative shall contact you with a Return material Authorization. If a replacement order is needed please inform customer service at the time of RMA issuance. - Discontinue usage if packaging irregularities exist - Return RMA units to Leoni Fiber Optics Inc. - Inform Customer Service if replacement product is required. - Complete acknowledge form and return back to Leoni Fiber Optics Inc. Attention Roger West, LFOI Quality Manager, Roger.West2@leoni.com If you have any questions, please contact Quality Manager at 757-258-4805 or Email: Roger.West2@leoni.com.
Distribution US Distribution to the state of: Ohio.
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 = GEX and Original Applicant = FIBERTECH GMBH
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