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U.S. Department of Health and Human Services

Class 2 Device Recall monopolar pencil

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  Class 2 Device Recall monopolar pencil see related information
Date Initiated by Firm May 11, 2018
Create Date May 25, 2018
Recall Status1 Terminated 3 on April 15, 2019
Recall Number Z-1941-2018
Recall Event ID 80080
510(K)Number K936304  
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
Product Symmetry Olsen Monopolar Pencil:
(a) Button Switchpen, w/ Standard Needle Electrode REF 75505, QTY 50
(b) Button Switchpen, w/ Standard Blade Electrode, REF 75530, QTY 50
(c) Rocker Switchpen, w/ Standard Blade Electrode, REF 75610, QTY 50
(d) Button Switchpen, w/ Extendable Blade Electrode, 10 mm Exposure, REF 75800, QTY 25
(e) Button Switchpen, w/ Extendable Blade Electrode, 2 mm Exposure, REF 75810, QTY 25
(f) Button Switchpen, w/ Extendable Needle Electrode, 2 mm Exposure, REF 75820, QTY 25
(g) Foot Controlled Handle, w / Standard Blade electrode, REF 95012, QTY 100

Designed to hold active electrodes.






Code Information all codes
Recalling Firm/
Manufacturer		 Olsen Medical
3230 Commerce Center Pl
Louisville KY 40211-1900
For Additional Information Contact
502-772-4272
Manufacturer Reason
for Recall		 Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised.
FDA Determined
Cause 2		 Package design/selection
Action Symmetry initiated their recall via Urgent Medical Device Recall notices on 05/11/2018 sending faxes to accounts, as applicable; and, will also send the Notice via US certified mail, with return receipt requested, and will also send the Notice via e-mail to those customers for which it has a valid e-mail address (as applicable). All customers were asked to quarantine any products that reflect a breach of the seal area or any products that they do not wish to inspect immediately and promptly call (800) 251-3000 for a return material authorization (RMA) number to support the return of the impacted Products. All customers outside of the United States (OUS) will be provided with the Notice via postal mail and through Symmetrys Distributors in each country and requested to quarantine immediately and promptly call Symmetry's Distributors to support the return of any products that have a breach of the seal area or which the customer does not wish to inspect. Appropriate notifications will be sent to Health Authorities in Canada, European Union, and other countries that require notification of this recall.
Quantity in Commerce 665,350 devices
Distribution Worldwide Distribution
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 = E & M ENGINEERING, INC.
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