Events

Recall of BIO-EYE HYDROXYAPATITE OCULAR IMPLANT - P-K THREADED SLEEVE & P-K FLAT PEG

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by INTEGRATED ORBITAL IMPLANTS INC..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    15409
  • Event Risk Class
    III
  • Event Initiated Date
    2007-02-15
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Threaded sleeve and flat peg are two components of the perry-kolberg titanium motility/support system. the threads on the threaded sleeve have left-handed threads rather than specified right-handed threads.

Device

BIO-EYE HYDROXYAPATITE OCULAR IMPLANT - P-K THREADED SLEEVE & P-K FLAT PEG
  • Model / Serial
    Model Catalog: I00045 (Lot serial: M-50021); Model Catalog: I00044 (Lot serial: M-50021)
  • Product Description
    P-K Threaded Sleeve and Flat Peg
  • Manufacturer
    INTEGRATED ORBITAL IMPLANTS INC.

Manufacturer

INTEGRATED ORBITAL IMPLANTS INC.
  • Manufacturer Address
    SAN DIEGO
  • Source
    HC