Recall Z-2292-2010 ยท HPZ Implant, Eye Sphere
Integrated Orbital Implants Inc
Sterile Bio-Eye Hydroxyapatite Orbital Implant and Conformer
| Date | Aug 26, 2010 (initiated Jun 7, 2010) |
| Status | Terminated |
| Reason | Integrated Orbital Implants, Inc. has initiated a recall of it's Sterile Bio-Eye Hydroxyapatite Orbital Implant and Conformer due to a labeling issue in which the expiration date of the product was omitted. |
| Root cause | Error in labeling |
| Action | Customers were contacted by telephone and email |
| Quantity | 40 units |
| Distribution | USA (MT, AL, IN, IA, NY, KY, IL, MI, and FL), Canada, Germany, and Turkey |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982562 | BIO-EYE HYDROXYAPATITE OCULAR IMPLAND AND CONFORMER Integrated Orbital Implants, Inc., Dec 28, 1998 |