Bio-Eye Hydroxyapatite (HA) Orbital Implant and Conformer, Model Number: 100020S
FDA Recall Z-0012-2007 · Posted 2006-10-04
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Recalling FirmIntegrated Orbital Implants Inc
Recall StatusTerminated
Product CodeHPZ
Date Initiated2006-02-27
Date Terminated2006-10-05
Product Quantity8
Reason for Recall
The end label on the outer box was mislabeled on 9 of a 10 unit lot. The end label says ''22 mm'' and the implants are actually ''20 mm''. The main label on the cardboard box applied by the contract packager is correct in identifying the product as ''20 mm''.
Firm Action
The recall was to the distributor level. From contact with the two distributors involved, it was determined that all of the product affected was still with the two distributors.
Both distributors affected were notified via email 2/27/2006. The correct labels were shipped by FEDEX to each of them.
Both distributors were instructed to check their inventory of this lot number and confirm if the end labels were in conflict with the main outer box label. When this was confirmed, the distributor was instructed to apply the correct end labels supplied.
Root Cause
Other
Distribution Pattern
Internationally to Finland & France
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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