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Terminated

Sterile Bio-Eye Hydroxyapatite Orbital Implant and Conformer

FDA Recall Z-2292-2010 · Posted 2010-08-26

Recalling FirmIntegrated Orbital Implants Inc
Recall StatusTerminated
Product CodeHPZ
Date Initiated2010-06-07
Date Terminated2010-08-31
Product Quantity40 units

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.

Firm Action

Customers were contacted by telephone and email

Root Cause

Error in labeling

Distribution Pattern

USA (MT, AL, IN, IA, NY, KY, IL, MI, and FL), Canada, Germany, and Turkey

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K982562BIO-EYE HYDROXYAPATITE OCULAR IMPLAND AND CONFORMERIntegrated Orbital Implants, Inc. · 1998-12-28

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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