Recall Z-0918-03 ยท HNN Knife, Ophthalmic
Surgical Specialties Puerto Rico, Inc.
2.75 mm Slit Knife, Angled, Bevel Up. Labeled '' Stylus *** 2.75 mm Slit Knife Angled, Bevel, Up***One Unit STERILE R Disposable***Surgical Specialties Corporation***Reading, PA 19606***''
| Date | Jun 5, 2003 (initiated May 7, 2003) |
| Status | Terminated |
| Reason | Incorrect handle was used in the manufacture of product 52-2761 |
| Root cause | Other |
| Action | On 5/7/03 the cusotmers were notified of the recall via fax. |
| Quantity | 3,420 pieces |
| Distribution | Nationwide and worldwide. Distribution was to two accounts in the USA and four (4) foreign accounts. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K822112 | OPHTHALMIC KNIFE Sharpoint, Inc., Aug 10, 1982 |