Events

Recall of SMR glenosphere impactor/extractor

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
    73870
  • Event Risk Class
    Class 2
  • Event Number
    Z-1711-2016
  • Event Initiated Date
    2016-04-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-12-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145221
  • 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, semi-constrained, metal/polymer cemented - Product Code KWS
  • Reason
    Complaints of intra-operative breakage of the glenosphere impactors/extractors.
  • Action
    The affected firms received written notification to all distributors. The letter instructed the consignee to identify and remove all affected product in stock and return parts to Lima USA.

Device

SMR glenosphere impactor/extractor
  • Model / Serial
    Lot numbers: 1390763, 14AA094, 14AA431, 14AA528, 15AA094, 15AA557, 15AA558, 15AA559, 15AA600
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed US (nationwide) and in Australia.
  • Product Description
    SMR glenosphere impactor/extractor; Used to implant the glenosphere in the SMR Reverse Shoulder replacement.
  • 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