Z-0012-2007

Bio-Eye Hydroxyapatite (HA) Orbital Implant and Conformer, Model Number: 100020S

Name: Z-0012-2007 Bio-Eye Hydroxyapatite (HA) Orbital Implant and Conformer, Model Number: 100020S
Creator: Integrated Orbital Implants Inc
Published: 2006-02-27
License: https://open.fda.gov/license/

Integrated Orbital Implants Inc / initiated 2006-02-27 / Terminated / root cause: labeling and UDI

FDA source

Integrated Orbital Implants Inc began a recall of Bio-Eye Hydroxyapatite (HA) Orbital Implant and Conformer, Model Number: 100020S on 2006-02-27. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0012-2007
Status: Terminated
Initiated: 2006-02-27
Posted: 2006-10-04
Terminated: 2006-10-05
Recalling firm: Integrated Orbital Implants Inc
Product: Bio-Eye Hydroxyapatite (HA) Orbital Implant and Conformer, Model Number: 100020S
Product code: HPZ Implant, Eye Sphere
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''.
Root cause tag: labeling and UDI
FDA root cause: Other
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.
Quantity in commerce: 8
Distribution: Internationally to Finland & France
Product codes and lots: Lot/Unit Codes: 976115CC, Serial Numbers: 2000509, 207025, 207557, 44993, 62774, 205928, 201933, 203550, 205927, 202939

Product code HPZ

K982562Class IIBio-Eye Hydroxyapatite Ocular Impland and ConformerIntegrated Orbital Implants, Inc. / cleared 1998-12-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)