Recall Z-0633-2024 ยท HNN Knife, Ophthalmic
Beaver Visitec International, Inc.
Xstar Kojo Safety Slit Knife, 2.5mm 45 Bevel Up, Part Number 373025
| Date | Jan 4, 2024 (initiated Oct 10, 2023) |
| Status | Open, Classified |
| Reason | One lot of Part Number 373025, Xstar Kojo Safety Slit Knife 2.5mm 45 bevel up, incorrectly contains a bevel down blade instead of a bevel up blade. |
| Root cause | Under Investigation by firm |
| Action | An "URGENT Field Safety Notice" dated 10/10/23 was sent to customers. Actions Required by You Our records show you received one or more affected product. You can recognize the affected product by determining whether the lot number printed on the device label is one of the affected lots. PLEASE perform the following actions: 1. Immediately examine your inventory and determine if the blades on the knives are bevel-up as intended or bevel down. Only destroy the knives in your inventory that have the incorrect bevel orientation (bevel down). If you have further distributed this product, please n |
| Quantity | 2160 units |
| Distribution | International Distribution to Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.