Device recall
Z-1673-2012: HPBLUE: HARMONIC Blue Hand Piece; HP054: HARMONIC Hand Piece; Non-Sterile…
FDA device recall · Class II · Ethicon Endo-Surgery Inc
Key facts
| Recall number (Z-number) | Z-1673-2012 |
|---|---|
| Recall event | 61540 |
| Product | HPBLUE: HARMONIC Blue Hand Piece; HP054: HARMONIC Hand Piece; Non-Sterile products are individually packed in a poly bag and then placed into an individual carton. Mfr. By: Ethicon Endo-Surgery, LLc, 475 Calle C, Guaynbo, PR 00969. Indicated for soft tissue incisions when bleeding control and… |
| Product code | LFL |
| Recalling firm | Ethicon Endo-Surgery Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 5, 2013 |
| 510(k) numbers | K063192 |
| FEI number | 1527736 |
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