Milagro

Main information

  • Trade name:
  • Milagro BR Interference Screws (Short Lengths) - Prosthesis, internal, ligament, anchor
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Milagro BR Interference Screws (Short Lengths) - Prosthesis, internal, ligament, anchor
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217763
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217763

Johnson & Johnson Medical Pty Ltd T/A Depuy Australia - Milagro BR Interference Screws (Short Lengths)

- Prosthesis, internal, ligament, anchor

ARTG entry for

Medical Device Included Class III

Sponsor

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Postal Address

PO Box 134,NORTH RYDE, NSW, 2113

Australia

ARTG Start Date

26/11/2013

Product category

Medical Device Class III

Status

Active

Approval area

Medical Devices

Conditions

- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,

Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations

2002 for relevant information.

- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal

offence; and civil penalties may apply.

Manufacturers

Name

Address

Depuy Mitek (a Johnson & Johnson Company)

325 Paramount Drive

Raynham, MA, 02767

United States Of America

Products

1. Milagro BR Interference Screws (Short Lengths) - Prosthesis, internal, ligament, anchor

Product Type

Single Device Product

Effective date

26/11/2013

GMDN

36174 Ligament anchor

Functional description

The DePuy Mitek MILAGRO BR interference screw is a threaded, cannulated, threaded fastener for use in

fixation of soft tissue to bone grafts. Thebiocomposite interference screw is made from absorbable

BIOCRYL® RAPIDE™ (PLGA/ß-TCP) material.

Intended purpose

The DePuy Mitek MILAGRO BR Interference Screws (Small Lengths) are designed to attach soft tissues

to bone in orthopedic surgical procedures for the following indications:

Shoulder: Proximal Biceps Tenodesis, Acromio-Clavicular Repair

Elbow: Distal Biceps Tenodesis, Ulnar Collateral Ligament Repair

Knee: Collateral Ligament Repair

Variant information

Diameter (mm) 5 - 8

Length (mm) 12 & 15

Specific Conditions

No Specific Conditions included on Record

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 02.12.2017 at 04:52:41 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

13-11-2018

Alebrije Dist Wholesale Recalls Quesillo Queseria “La Milagrosa” and “Alebrije Cheese” Because of Possible Health Risk

Alebrije Dist Wholesale Recalls Quesillo Queseria “La Milagrosa” and “Alebrije Cheese” Because of Possible Health Risk

ALEBRIJE DIST WHOLESALE is collaborating with health officials due to a positive finding of Salmonella in a sample of Quesillo “Queseria La Milagrosa”. ALEBRIJE DIST WHOLESALE is voluntarily recalling the amount of 100 kilos of Quesillo “Queseria La Milagrosa”. While “Alebrije Cheese” has not been found positive for Salmonella, ALEBRIJE DIST WHOLESALE has decided to voluntarily recall the specific 498 “Alebrije Cheese” pieces that were imported during the same period out of an abundance of caution.

FDA - U.S. Food and Drug Administration

There are no news related to this product.