Device 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
Z-1753-2015
Product summary
- Event
- Event 71238
- Status
- Terminated
- Classification
- Class II
- Quantity
- 22,250 boxes
- Official record key
device-enforcement:Z-1753-2015
Official wording
Reason: Potential lack of sterility assurance.
Code information: Lot Number: JC24165
Distribution pattern: Nationwide and Canada, Australia, Germany, New Zealand, Japan, India, Great Britain
Derived failure modes
-
Sterility assurance
lack of sterility