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U.S. Department of Health and Human Services

Class 2 Device Recall Gyrus ACMI Diego Elite Tubeset

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  Class 2 Device Recall Gyrus ACMI Diego Elite Tubeset see related information
Date Initiated by Firm May 08, 2015
Date Posted June 11, 2015
Recall Status1 Terminated 3 on May 17, 2016
Recall Number Z-1753-2015
Recall Event ID 71238
510(K)Number K123429  
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
Product Gyrus ACMI Diego Elite Tubeset, intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft and hard tissue in general ENT, Sinus/Rhinology, Nasopharyngeal/Laryngology, and Head and Neck procedures. Catalog No. TS101DC, Lot numbers JC924165 and below; Rx Only, STERILE EO
Code Information Lot Number: JC24165
Recalling Firm/
Manufacturer		 Gyrus Acmi, Incorporated
136 Turnpike Road
Southborough MA 01772-2118
For Additional Information Contact Terrence E. Sullivan
508-804-2739
Manufacturer Reason
for Recall		 Potential lack of sterility assurance.
FDA Determined
Cause 2		 Under Investigation by firm
Action The firm notified their direct accounts of the recall by Fed Ex Second Day on 05/08/2015. The letter requesting disposal of the product was extended to hospitals or medical practices that purchased the product. Non-responding consignees will be contacted again if necessary.
Quantity in Commerce 22,250 boxes
Distribution Nationwide and Canada, Australia, Germany, New Zealand, Japan, India, Great Britain
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 = GYRUS ACMI, INC.
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