Events

Recall of Device Recall Bencox Mirabo PE Liner36/44 Model Number: H1.L61.3644, UDI: 8806373852343

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

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
    76587
  • Event Risk Class
    Class 2
  • Event Number
    Z-1454-2017
  • Event Initiated Date
    2017-02-27
  • Event Date Posted
    2017-03-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-05-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153590
  • 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, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
  • Reason
    Lot may contain the wrong instruction (instruction for chinese customer) instead of correct us instructions for use.
  • Action
    Corentec sent an Medical Device Recall letter dated February 23, 2017. The recalling firm notified the consignee via written notification by email and by phone. The recalled products will be returned to the recalling firm. For further questions please call (512) 327-9997

Device

Device Recall Bencox Mirabo PE Liner36/44 Model Number: H1.L61.3644, UDI: 8806373852343
  • Model / Serial
    Lot Number: 10AFFQ21 Expiration Date: 2021-11-28
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Distribution to the state of : PA
  • Product Description
    Bencox Mirabo PE Liner 36/44 Model Number: H1.L61.3644, UDI: 8806373852343
  • Manufacturer
    CORENTEC CO., LTD

Manufacturer

CORENTEC CO., LTD
  • Manufacturer Address
    CORENTEC CO., LTD, Seobuk-gu, 12 Yeongsanhong 1-gil, Seobuk-gu, Cheonan-si Korea (the Republic of)
  • Manufacturer Parent Company (2017)
    Corentec Co., Ltd.
  • Source
    USFDA