Device recall
Z-2651-2010: GYRUS ACMI, dissector PlasmaKnife", REF 7035-3005, Rx only, STERILE R, CE 0344…
FDA device recall · Class II · Gyrus Acmi, Incorporated
Key facts
| Recall number (Z-number) | Z-2651-2010 |
|---|---|
| Recall event | 56304 |
| Product | GYRUS ACMI, dissector PlasmaKnife" , REF 7035-3005, Rx only, STERILE R, CE 0344, 161416-CA, MANUFACTURED FOR; GYRUS ACMI, INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA 01722-2104, USA, EC REP, GYRUS MEDICAL LIMITED, FORTRAN ROAD, ST. MELLONS, CARDIFF, CF3 0LT, UK |
| Product code | GEI |
| Recalling firm | Gyrus Acmi, Incorporated |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 26, 2012 |
| 510(k) numbers | K041285 |
| 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