MILAGRO

Main information

  • Trade name:
  • MILAGRO Advance Interference Screw - Fixation screw, bone, biodegradable
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • MILAGRO Advance Interference Screw - Fixation screw, bone, biodegradable
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218737
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218737

Johnson & Johnson Medical Pty Ltd T/A Depuy Australia - MILAGRO Advance Interference Screw -

Fixation screw, bone, biodegradable

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

20/12/2013

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 Advance Interference Screw - Fixation screw, bone, biodegradable

Product Type

Single Device Product

Effective date

20/12/2013

GMDN

45039 Fixation screw, bone, biodegradable

Functional description

The MILAGRO ADVANCE Interference Screws are absorbable, tapered, cannulated and threaded

interference screws manufactured from Biocryl Rapide material. The screw is designed for use in

interference fixation of soft tissue grafts or bone-tendon-bone grafts to bone.

Intended purpose

The MILAGRO ADVANCE Interference Screw is intended for attachment of soft tissue grafts or

bone-tendon-bone grafts to the tibia and/or femur during cruciate ligament reconstruction procedures.

Additionally, the 7, 8 and 9 mm x 23 mm screws are indicated for: medial and lateral collateral ligament

repair of the knee, proximal bicep tenodesis in the shoulder and distal bicep tenodesis in the elbow.

Variant information

Length (mm) 23-35

Diameter (mm) 7-12

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 04:43:48 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.