Events

Safety Alert for Sterile & Non-Sterile Individually Packaged BOLD 2.5 Compression Screw

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Newdeal SAS.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2015-11-03
  • Event Date Posted
    2015-11-03
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20151103b.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: newdeal sterile & non-sterile individually packaged bold 2.5 compression screw the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning sterile & non-sterile individually packaged bold 2.5 compression screw, manufactured by newdeal sas, a company within integra lifesciences group. the affected catalog numbers are 200010, 200010s, 200016 and 200016s. batches f9sp and fagj are involved. the manufacturer has recently identified that some screws from one batch of bold 2.5 compression screw, length 16 mm (catalog number 200016 – batch fagj) have been packaged and labeled with the specifications of bold 2.5 compression screw, length 10mm (catalog number 200010 – batch f9sp). as a consequence: if a shorter screw was inadvertently used based on the labeling, the screw might not have enough threads to engage intended structures resulting in inadequate fixation or reconstruction. if a longer screw was inadvertently used based on the labeling, the shaft or tip of the screw might penetrate unintended structures (bone, vessel, tissue), resulting in damage to those structures. the manufacturer has made a decision to conduct a voluntary recall of the two batches. for details, please refer to the mhra websites:https://www.Gov.Uk/government/publications/safety-information-from-manufacturers-field-safety-notices/field-safety-notices-26-to-30-october-2015 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 3 november 2015.

Device

Sterile & Non-Sterile Individually Packaged BOLD 2.5 Compression Screw
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Newdeal Sterile & Non-Sterile Individually Packaged BOLD 2.5 Compression Screw
  • Manufacturer
    Newdeal SAS

Manufacturer

Newdeal SAS