Events

Recall of SynReam Reaming Rod 2.5mm, L 650mm, sterile(re-usable surgical instrument supplied as part of the SynReam Reaming medullary reaming system)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes.

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
    RC-2016-RN-01372-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-10-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01372-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    An issue has been identified where peel pouches for certain lot numbers of reaming rods are de-laminating. this may lead to surgical staff members experiencing difficulty in opening the peel pouches and potentially causing the sterile device to come in contact with a non-sterile layer of the pouch.In the event there is difficulty in opening the sterile peel pouch a surgical delay may occur while a replacement part is located or while re-sterilisation is performed. if surgery cannot be completed without the sterile part and no alternate is available, the procedure may need to be rescheduled. if there is delamination of the peel pouches the layering and fragments may compromise the sterility of the part, which may place the patient at risk for infection.
  • Action
    Johnson & Johnson is advising customers to immediately quarantine affected product. Affected product may then be returned to Johnson & Johnson for replacement or unopened affected product may be re-sterilised per the product Sterilisation Instructions contained within the Instructions for Use provided with the product.

Device

SynReam Reaming Rod 2.5mm, L 650mm, sterile(re-usable surgical instrument supplied as part of the...
  • Model / Serial
    SynReam Reaming Rod 2.5mm, L 650mm, sterile(re-usable surgical instrument supplied as part of the SynReam Reaming medullary reaming system)Part Number: 351.709SLot Numbers: 9913259, 9913260, 9963747, 9963748, 9963749, 9963751, 9963752, 9963753, 9963755, 9963756, 9963757, H040517, H040518, H060114, H060115, H060116, H080081, H080082, H080083, H080084, H080085, H080086, H080087, H080088, H080089, H105530ARTG Number: 15395
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes