Recall Z-0705-03 ยท HNN Knife, Ophthalmic
Surgical Specialties Corp
Sharpoint ClearTrap Trapezoid Clear Corneal/Implant Knife. Ophthalmic Knife 2.5 mm x 3.5 mm.
| Date | Apr 1, 2003 (initiated Jan 7, 2003) |
| Status | Terminated |
| Reason | size mislabeled on product handle |
| Root cause | Other |
| Action | On 1/7/03, one account was contacted via telephone. On 1/10/03, a recall letter was faxed to that account. On 3/11/03, this wholesale account was asked to contact a hospital sub account that received a direct shipment. The other account was the complainant and telephone communications were occurring. |
| Quantity | 635 units |
| Distribution | The product was shipped to 2 wholesale accounts in PA and LA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K822112 | OPHTHALMIC KNIFE Sharpoint, Inc., Aug 10, 1982 |