Recall Z-0026-04 ยท HNN Knife, Ophthalmic
Surgical Specialties Corp
Sharpoint 2.75 mm x 3.75 mm ClearTrap Trapezoid Knife Clear Corneal Implant Angled. The product can be sold as an individual unit or in a box of 6 knives.
| Date | Oct 15, 2003 (initiated Aug 21, 2003) |
| Status | Terminated |
| Reason | text on product handle is incorrect |
| Root cause | Other |
| Action | The consignees were notified via fax on 8/21/03. One customer received a recall letter via mail on 8/22/03. |
| Quantity | 666 units |
| Distribution | The products were shipped to two hospitals in CA, two sales representatives in NC & IL, and three wholesalers in IL, Belgium, Canada, and Austrailia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K822112 | OPHTHALMIC KNIFE Sharpoint, Inc., Aug 10, 1982 |