Events

Recall of Device Recall Joseph Lamelas Atrial Lift System; Atrial Lift System

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

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
    68093
  • Event Risk Class
    Class 2
  • Event Number
    Z-1538-2014
  • Event Initiated Date
    2014-03-19
  • Event Date Posted
    2014-05-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-08-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126934
  • 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
    Instruments, surgical, cardiovascular - Product Code DWS
  • Reason
    The support arm attached with an adhesive to the body of the blade is detaching while attempting to engage the visor component.
  • Action
    Biorep Technologies sent a letter dated March 19, 2014, to its affected customer. It was advised to due to the high risk, according to our risk categories shown in Table 2, at this time, it is recommended that product be retrieved from its points of use. Any further questions please call (305) 687-8074.

Device

Device Recall Joseph Lamelas Atrial Lift System; Atrial Lift System
  • Model / Serial
    Lot numbers: 166934413 (expires 2016/12/10), and 166903414 (expires 2017/02/03).
  • Product Classification
    Cardiovascular Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Distribution to a distributor in MN.
  • Product Description
    Joseph Lamelas Atrial Lift System, Model Number MI-ALS-001. A single surgical instrument or tool for retraction of the atrial wall tissue in cardiac surgery.
  • Manufacturer
    Biorep Technologies

Manufacturer

Biorep Technologies
  • Manufacturer Address
    Biorep Technologies, 3225 Nw 112th St, Miami FL 33167-3310
  • Manufacturer Parent Company (2017)
    Biorep Technologies Inc.
  • Source
    USFDA