Events

Recall of Device Recall TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Waldemar Link GmbH & Co. KG (Corp. Hq.).

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
    65800
  • Event Risk Class
    Class 2
  • Event Number
    Z-2079-2013
  • Event Initiated Date
    2013-07-16
  • Event Date Posted
    2013-08-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-06-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120219
  • 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
    Template - Product Code HWT
  • Reason
    The trial stems were manufactured using the wrong design.
  • Action
    The firm notified their consignees of their product recall by parcel post on 07/16/2013.

Device

Device Recall TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS
  • Model / Serial
    Lots: B225115, B048089, B102030
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Distribution to the state of Tennessee only.
  • Product Description
    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/22, Stem size S-5, prox. Stem dia. 22.5 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
  • Manufacturer
    Waldemar Link GmbH & Co. KG (Corp. Hq.)

Manufacturer

Waldemar Link GmbH & Co. KG (Corp. Hq.)
  • Manufacturer Address
    Waldemar Link GmbH & Co. KG (Corp. Hq.), Barkausenweg 10, Hamburg Germany
  • Manufacturer Parent Company (2017)
    Link Holding Gmbh
  • Source
    USFDA