Events

Recall of Lima SMR System glenoid components

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Lima-Lto SpA.

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
    13325
  • Event Initiated Date
    2012-08-23
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Lima Orthopaedics New Zealand Ltd, 20 Crummer Road, Grey Lynn, AUCKLAND 1021
  • Reason
    Monitoring and analysis of the clinical results of the smr l2 metal back glenoid component indicate that under certain conditions, for example rotator cuff failure or patient trauma, the polyethylene insert can disassociate. the total revision rate of the l2 version of the smr metal back glenoid componet in australia is 6.78% at three years.
  • Action
    Manufacturer to issue advice regarding use

Device

Lima SMR System glenoid components
  • Model / Serial
    Model: all models, Affected: all batch numbers
  • Manufacturer
    Lima-Lto SpA

Manufacturer

Lima-Lto SpA