Z-1752-2015 Class II Terminated
FDA device recall Z-1752-2015 was initiated by Gyrus Acmi, Incorporated on May 8, 2015 and is designated Class II. Reason for recall: Potential lack of sterility assurance. The recall status is terminated (terminated May 17, 2016). Affected quantity: 12,020 boxes.
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
- 12,020 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 & Neck procedures. Catalog No. TS100S, Lot numbers JC929332 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: JC929332