Z-2292-2010

Sterile Bio-Eye Hydroxyapatite Orbital Implant and Conformer

Name: Z-2292-2010 Sterile Bio-Eye Hydroxyapatite Orbital Implant and Conformer
Creator: Integrated Orbital Implants Inc
Published: 2010-06-07
License: https://open.fda.gov/license/

Integrated Orbital Implants Inc / initiated 2010-06-07 / Terminated / root cause: labeling and UDI

FDA source

Integrated Orbital Implants Inc began a recall of Sterile Bio-Eye Hydroxyapatite Orbital Implant and Conformer on 2010-06-07. The reason FDA records is "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". 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-2292-2010
Status: Terminated
Initiated: 2010-06-07
Posted: 2010-08-26
Terminated: 2010-08-31
Recalling firm: Integrated Orbital Implants Inc
Product: Sterile Bio-Eye Hydroxyapatite Orbital Implant and Conformer
Product code: HPZ Implant, Eye Sphere
Reason for recall: 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 tag: labeling and UDI
FDA root cause: Error in labeling
Action: Customers were contacted by telephone and email
Quantity in commerce: 40 units
Distribution: USA (MT, AL, IN, IA, NY, KY, IL, MI, and FL), Canada, Germany, and Turkey
Product codes and lots: Lot# 528020R - Serial Numbers: 55839, 60778, 60848, 60957, 61391, 170021, 185765, 185766, 185768, 185769, 185946, 190014, 190015, 190018, 2004053, 2004578, 209584, 209585, 209586, 209587, 209611, 209627, 209628, 209629, 209631, 170022, 170023, 190019, 190021, 190025, 220048, 222535, 53049, 62327, 223207, 240031, 240032, 240039, 240040, 240048

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)