Device recall
Z-1753-2015: Gyrus ACMI Diego Elite Tubeset, intended for cutting, coagulation, drilling…
FDA device recall · Class II · Gyrus Acmi, Incorporated
Key facts
| Recall number (Z-number) | Z-1753-2015 |
|---|---|
| Recall event | 71238 |
| 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 |
| Product code | GEI |
| Recalling firm | Gyrus Acmi, Incorporated |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 17, 2016 |
| 510(k) numbers | K123429 |
| FEI number | 3003790304 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database