Events

Recall of Device Recall Ascension Orthopedics PyroSphere CMC & PyroSphere TMT

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Integra LifeSciences Corp..

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
    69719
  • Event Risk Class
    Class 2
  • Event Number
    Z-0813-2015
  • Event Initiated Date
    2014-11-06
  • Event Date Posted
    2014-12-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-08-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131421
  • 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
    Prosthesis, toe, hemi-, phalangeal - Product Code KWD
  • Reason
    Integra lifesciences has determined that a portion of some specific lots of size 10 pyrosphere cmc and pyrosphere tmt devices are non-radiopaque.
  • Action
    The firm sent out written notification of the recall on 11/6/14. The letter instructed the consignees to quarantine and return any affected product.

Device

Device Recall Ascension Orthopedics PyroSphere CMC & PyroSphere TMT
  • Model / Serial
    Lot numbers: 140098T and 140929T
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    WA, Australia, and France
  • Product Description
    Ascension Orthopedics PyroSphere CMC & PyroSphere TMT, intended to replace the joint between the first metacarpal and the trapezium and 4th/5th tarsometatarsal where degenerative of post-traumatic arthritis presents. Size 10; Catalogue No. PCS-430-10-WW
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.