Events

Recall of Device Recall Surgical Instrument for SMR Anatomic and Reverse Shoulder Prosthesis

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
    74827
  • Event Risk Class
    Class 2
  • Event Number
    Z-2707-2016
  • Event Initiated Date
    2016-07-21
  • Event Date Posted
    2016-08-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-01-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148532
  • 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
    Orthopedic manual surgical instrument - Product Code LXH
  • Reason
    Product found to be dimensionally non-conforming (slightly over dimensioned on the diameter of the zimmer connection) and non-functional for connecting with some t-handles.
  • Action
    The firm received two complaints from the US field about the inta-operative malfunction with the SMR allen wrench 5mm (product code 9013.50.210) with the T-handle. Both parts involved were manufactured with the same lot #14AA311. No adverse effects for patients reported.

Device

Device Recall Surgical Instrument for SMR Anatomic and Reverse Shoulder Prosthesis
  • Model / Serial
    14AA311
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US, Italy, Australia
  • Product Description
    SMR allen wrench 5 mm, product code 9013.50.210
  • 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