Recall Z-0946-04 ยท HNN Knife, Ophthalmic
Surgical Specialties Puerto Rico, Inc.
Stylus Angled Knife - 56-5361, Pilot Tip Knife, bevel up, angled, full handled, 3.2mm and 56-5161, Pilot Tip Knife, bevel up, angled, full handled, 5.2mm
| 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 |