Product Brand Name: Coated Bio-Eye Orbital Implant w/Conformer. Product Generic Name: Implant, Eye Sphere Wrap, Implant,

FDA device recall Z-2624-2011 · posted 2011-06-22 · Terminated

Recall details

Recalling firm

Integrated Orbital Implants Inc

Reason for recall

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.

Action taken

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 request an RMA number and shipping instructions. Also stated in the letter, IOI will replace Coated BioEye implants without expiration dates free of charge upon receipt of the implants labeled without expiration dates.

Root cause

Other

Status

Terminated

Product code

hpz

Quantity affected

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, Ita

Date initiated

2011-05-20

Date posted

2011-06-22

Date terminated

2012-01-11

Location

San Diego, CA

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