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Terminated

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

FDA Recall Z-1753-2015 · Posted 2015-06-11

Recalling FirmGyrus Acmi, Incorporated
Recall StatusTerminated
Product CodeGEI
Date Initiated2015-05-08
Date Terminated2016-05-17
Product Quantity22,250 boxes

Reason for Recall

Potential lack of sterility assurance.

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.

Root Cause

Under Investigation by firm

Distribution Pattern

Nationwide and Canada, Australia, Germany, New Zealand, Japan, India, Great Britain

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K123429OLYMPUS ENERGY POWER SYSTEM (EPS)Gyrus Acmi, Inc. · 2013-04-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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