Recall of ACUTWIST ACUTRAK COMPRESSION SCREW

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ACUMED LLC.

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
    153496
  • Event Risk Class
    III
  • Event Initiated Date
    2011-08-05
  • Event Country
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    Product is labeled as ai-0030-s batch 25012 but an ai-0028-s batch 248000 is inside the packaging. product is labeled as ai-0028-s batch 248000 but an ai-0030-s batch 250212 is inside the packaging. based on acumed's health hazard evaluation there is no additional risk to health tot he end user of this product. acumed received a customer complaint on 7/22/2011.

Device

  • Model / Serial
    Model Catalog: AI-0030-S (Lot serial: AI-0030-S Lot 250212); Model Catalog: AI-0028-S (Lot serial: AI-0028-S Lot 248000); Model Catalog: AI-0030-S (Lot serial: AI-0028-S Lot 248000); Model Catalog: AI-0028-S (Lot serial: AI-0030-S Lot 250212)
  • Product Description
    28 mm & 30 mm AcuTwist Acutrak Compression Screws
  • Manufacturer

Manufacturer

  • Manufacturer Address
    HILLSBORO
  • Manufacturer Parent Company (2017)
  • Source
    HC