Device recall
Z-0559-2009: Harmonic Scalpel Model #'s: ETHACE14S ETHACE23P ETHACE36P ETHCS14C ETHFCS9…
FDA device recall · Class II · Sterilmed Inc
Key facts
| Recall number (Z-number) | Z-0559-2009 |
|---|---|
| Recall event | 49510 |
| Product | Harmonic Scalpel Model #'s: ETHACE14S ETHACE23P ETHACE36P ETHCS14C ETHFCS9 ETHHDH05 ETHLCS-C5 and ETHLCSC5HA Intended for use in soft tissue incisions when bleeding control and minimal thermal injury are desired. |
| Product code | NLQ |
| Recalling firm | Sterilmed Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 26, 2011 |
| 510(k) numbers | K012571, K050343 |
| FEI number | 3001237663 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 Products in the same recall event
- 1–9 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