Events

Recall of Device Recall MEDPOR PLUS

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Howmedica Osteonics Corp dba Stryker Craniomaxillofacial.

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
    61620
  • Event Risk Class
    Class 2
  • Event Number
    Z-1435-2012
  • Event Initiated Date
    2012-03-20
  • Event Date Posted
    2012-04-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108551
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Implant, eye sphere - Product Code HPZ
  • Reason
    The medpor plus sst ez 22mm sphere implants are not within specification of 22mm +/- 8, therefore implant is not easily released from the syringe.
  • Action
    The sole distributor was notified by "Urgent Product Recall" letter on March 20, 2012. "Urgent Medical Device Recall" letters were sent to Stryker Customers on March 26, 2012. The letters described the product issue, hazards, and actions recommended to mitigate the risk. Customer number provided: (800) 962-6558.

Device

Device Recall MEDPOR PLUS
  • Model / Serial
    Catalog number: 80062, Lot Codes: F000689 and G004528.
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Distribution, the state of Michigan.
  • Product Description
    MEDPOR PLUS SST EZ 22mm Sphere Implant, Howmedica Osteonics Corp, 15 Dart Road, Newnan, GA 30265. MEDPOR PLUS Orbital Implants are intended to restore the volume of an enucleated or eviscerated eye globe.
  • Manufacturer
    Howmedica Osteonics Corp dba Stryker Craniomaxillofacial

Manufacturer

Howmedica Osteonics Corp dba Stryker Craniomaxillofacial
  • Manufacturer Address
    Howmedica Osteonics Corp dba Stryker Craniomaxillofacial, 15 Dart Rd, Newnan GA 30265-1017
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA