Recall Z-2161-2024 ยท HNN Knife, Ophthalmic
Beaver Visitec International, Inc.
Xstar Safety Slit Knife, 2.75 mm 45 Bevel Up, Model Number 378227
| Date | Jun 20, 2024 (initiated May 10, 2024) |
| Status | Open, Classified |
| Reason | The wrong configuration of the blade was in the package. The bevel was on the opposite side, instead of being in front (bevel up) it was in the back (bevel down). |
| Root cause | Process control |
| Action | An URGENT Field Safety Notice dated 5/10/24 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. In case you purchased the CustomEye Kit please be advised it is not possible to check the bevel orientation without losing the KIT sterility. In such case, |
| Quantity | 1300 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, UK, and Italy. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.