Recall Z-2624-2011 ยท HPZ Implant, Eye Sphere
Integrated Orbital Implants Inc
Product Brand Name: Coated Bio-Eye Orbital Implant w/Conformer. Product Generic Name: Implant, Eye Sphere Wrap, Implant, Orbital. Model Number: I0016C, I0018C, I0020C, I0022C, I0024C. Description of the product: The Coated Bio-Eye consists of a coralline hydroxyapatite sphere encased in a resorbable shell that aids in implant insertion and provides a means of securing muscles to the implant. T
| Date | Jun 22, 2011 (initiated May 20, 2011) |
| Status | Terminated |
| Reason | The recall was initiated because Integrated Orbital Implants has confirmed certain lots of the Coated Bio-Eye were manufactured without expiration dating visible on the packaging. All unlabeled product is currently beyond its expiration date. |
| Root cause | Other |
| Action | Integrated Orbital Implants Inc initiated a recall communication on 5/20/2011 with Integrated Orbital Implants (IOI) forwarding a Urgent Safety Notification letter to all their customers who had purchased the Coated Bio-Eye implants. The letter asked the customers to look for evidence of a printed expiration date on Coated Bio-eye package. If any Coated BioEye packages were not labeled with an expiration date the letter instructed customers to immediately sequester the products and not to use the products in surgery and contact IOI by telephone at (858) 6779990 or 1 (800) 4246537 to requ |
| Quantity | 4237 |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of nationwide and worldwide to: Japan, Greece, Germany, Romania, UAE, Australia, Canada, Philippines, Korea, Taiwan, Chile, Denmark, UK, Italy, Pakistan, Turkey, Philippines, India, South Africa, and Singapore. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K003338 | BIO-EYE II ORBITAL IMPLANT Integrated Orbital Implants, Inc., Feb 7, 2001 |