Events

Recall of Device Recall Fastlok Staple Impactor (6 mm size, 2023001)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Xiros Plc.

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
    35828
  • Event Risk Class
    Class 2
  • Event Number
    Z-1500-06
  • Event Initiated Date
    2006-05-17
  • Event Date Posted
    2006-09-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46972
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    ligament staple impactor - Product Code HXJ
  • Reason
    The impactors are being recalled for modification so that they can be disassembled fully for cleaning and sterilization, on suspicion that the assembled items retain contamination after cleaning and may not be effectively sterilized by the recommended hospital sterilization cycles.
  • Action
    Customer recall notifications included: a) Telephone notification to highest volume users b) Recall letters were sent via certified mail to all customers June 1, 2006. Customers were instructed to cease using immediately and return the Impactors to Tapco. The customers were instructed to call the firm for a return authorization number. Modified loaner Impactors will be made available to customers as soon as possible.

Device

Device Recall Fastlok Staple Impactor (6 mm size, 2023001)
  • Model / Serial
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide & Worldwide, including Spain, Japan, UAE, Italy, Germany
  • Product Description
    Neoligaments Staple Impactor, 6 mm Staple Impactor: 202-3001
  • Manufacturer
    Xiros Plc

Manufacturer

Xiros Plc
  • Manufacturer Address
    Xiros Plc, 28-30 Blenheim Terrace ., Leeds United Kingdom
  • Source
    USFDA