Device recall
Z-1022-2007: Zyoptix XP Epi Head, packaged 1 per container, Cat. #ZXP32040, packaged…
FDA device recall · Class II · Bausch & Lomb Inc
Key facts
| Recall number (Z-number) | Z-1022-2007 |
|---|---|
| Recall event | 38230 |
| Product | Zyoptix XP Epi Head, packaged 1 per container, Cat. #ZXP32040, packaged nonsterile and reuseable. Ophthalmic surgical accessory. NOTE: The label only names the product as Zyoptix XP Microkeratome. It does not reference the product as an Epi Head The product is labeled as Manufacturer: Bausch & Lomb… |
| Product code | HNO |
| Recalling firm | Bausch & Lomb Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 28, 2009 |
| 510(k) numbers | K040204 |
| FEI number | 1317628 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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