Home / Recalls / Gyrus Acmi, Incorporated / Z-1753-2015

Z-1753-2015 Class II Terminated

Recalled by Gyrus Acmi, Incorporated — Southborough, MA

Recall Details

Product Type
Devices
Report Date
June 17, 2015
Initiation Date
May 8, 2015
Termination Date
May 17, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
22,250 boxes

Product Description

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

Reason for Recall

Potential lack of sterility assurance.

Distribution Pattern

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

Code Information

Lot Number: JC24165

Other recalls by Gyrus Acmi, Incorporated

  • Z-1952-2018 Class II — Gyrus ACMI Reusable Active Cord for Bovie/ValleyLab Generators, Catalog No C650- (April 17, 2018)
  • Z-1752-2015 Class II — Gyrus ACMI Diego Elite Tubeset; intended for cutting, coagulation, drilling, deb (May 8, 2015)
  • Z-0419-2015 Class II — Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and REF 0 (October 21, 2014)
  • Z-1439-2013 Class II — GYRUS ACMI, MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLE, REF 130715, (May 24, 2013)
  • Z-0411-2013 Class II — PARPARELLA-TYPE VENT TUBE, 1.02 MM, SILICONE, REF 240044, QTY 6, Rx Only, STERI (October 17, 2012)