Events

Recall of Trial Humeral Head

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Limacorporate S.p.A.

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
    71972
  • Event Risk Class
    Class 2
  • Event Number
    Z-2539-2015
  • Event Initiated Date
    2015-08-14
  • Event Date Posted
    2015-09-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-02-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139473
  • 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, shoulder, non-constrained, metal/polymer cemented - Product Code KWT
  • Reason
    The dimensions of the mating features of the recalled products are out of specification causing the device to be difficult to assemble.
  • Action
    Lima Corporate sent an Urgent Attention Recall letter on August 11, 2015, to US distributors and Sales Agents. The affected customers were instructed to examine their inventory, return the affected lots to the recalling firm, and complete a response form.

Device

Trial Humeral Head
  • Model / Serial
    Lot Numbers: 14AA234, 14AA235, 14AA233
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Distribution to the states of: OH, TX, NC, NY, CA, FL, KS, AL, MI, MT, CO, MO, NV, WA, MN and LA., and Internationally to Australia.
  • Product Description
    SMR Shoulder/Spalla Trial Humeral Head diameter .42 mm, REF 9013.22.425; SMR Shoulder/Spalla Trial Humeral Head diameter .44 mm, REF 9013.22.445; || SMR Shoulder/Spalla Trial Humeral Head diameter .46 mm, REF 9013.22.465; for use in shoulder implant surgery.
  • Manufacturer
    Limacorporate S.p.A

Manufacturer

Limacorporate S.p.A
  • Manufacturer Address
    Limacorporate S.p.A, Via Nazionale 52, San Daniele Del Friuli Italy
  • Manufacturer Parent Company (2017)
    Emil Holding Ii Sarl
  • Source
    USFDA