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 & Neck procedures. Catalog No. TS100S, Lot numbers JC929332 and below, Rx Only, STERILE EO
Z-1752-2015
Product summary
- Event
- Event 71238
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12,020 boxes
- Official record key
device-enforcement:Z-1752-2015
Official wording
Reason: Potential lack of sterility assurance.
Code information: Lot number: JC929332
Distribution pattern: Nationwide and Canada, Australia, Germany, New Zealand, Japan, India, Great Britain
Derived failure modes
-
Sterility assurance
lack of sterility