Recall Z-0947-04 ยท HNN Knife, Ophthalmic
Surgical Specialties Puerto Rico, Inc.
Stylus Brand Angled Knife - 52-2661, Slit Knife, bevel up, angled full handled, 2.65mm 52-2761, Slit Knife, bevel up, angled, full handled, 2.75mm 52-2861, Slit Knife, bevel up, angled, full handled, 2.85mm 52-2961, Slit Knife, bevel up, angled, full handled, 3.0mm 52-3261, Slit Knife, bevel up, angled, full handled, 3.2mm 52-3561, Slit Knife, bevel up, angled, full handled, 3.5mm 52-2662, Slit Kn
| Date | Jul 20, 2004 (initiated Mar 3, 2004) |
| Status | Terminated |
| Reason | Incorrect placement of the blade in the foam of product results in blade poking through packaging. Compromised sterility and injury to healthcare worker. |
| Root cause | Other |
| Action | Customers were notified by e-mail and fax of the recall during the period of March 3, 2004 to April 1, 2004. Customers were requested to return the product to Surgical Specialties Corporation, Reading, PA 19606. |
| Distribution | Distribution was nationwide and internationally |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K822112 | OPHTHALMIC KNIFE Sharpoint, Inc., Aug 10, 1982 |