Class 2 Device Recall Gyrus ACMI Diego Elite Tubeset

• Date Initiated by Firm: May 08, 2015
• Date Posted: June 11, 2015
• Recall Status: Terminated on May 17, 2016
• Recall Number: Z-1752-2015
• 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 & Neck procedures. Catalog No. TS100S, Lot numbers JC929332 and below, Rx Only, STERILE EO
• Code Information: Lot number: JC929332
• 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: 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: 12,020 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