Recall Z-0712-05 ยท HPZ Implant, Eye Sphere
Porex Surgical, Inc.
MEDPOR Surgical Implant * POREX Surgical Products Group * Sterile/EO * Implant, Non-Pyrogenic, For Single Use Only, CAT #6317 DIM 20mm Diameter * Lot xxxxxx * QTY: 1 * Porex Surgical Inc., 15 Dart Road, Newnan, GA 30265 USA
| Date | Apr 16, 2005 (initiated Mar 7, 2005) |
| Status | Terminated |
| Reason | The product, which is a 20mm MEDPOR Sphere, was mislabeled in that the package contained 18mm MEDPOR Spheres |
| Root cause | Other |
| Action | On 03/07/2005 and 03/08/2005 consignees were notified via email and telephone. A follow up letter was being sent. |
| Quantity | 30 units |
| Distribution | AZ, IL, NJ and Korea |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K863943 | POREX(TM) EYE SPHERE IMPLANT Porex Medical, Feb 27, 1987 |