Events

Recall of System 26 Headed and Headless Bone Screw and Washer System

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

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
    79218
  • Event Risk Class
    Class 2
  • Event Number
    Z-0967-2018
  • Event Initiated Date
    2017-10-10
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161670
  • 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
    Screw, fixation, bone - Product Code HWC
  • Reason
    Following the identification of corrosion residue found inside the cannulated devices in forefoot and midfoot trays orhto solutions group has taken the decision to recall all x106 system 26 forefoot and midfoot implants and instruments tray from the us market.
  • Action
    Ortho Solutions notified customers of the recall via letter 10/10/2017. The recall notification letter was accompanied by instructions to Distributors and a Product Removal Form.

Device

System 26 Headed and Headless Bone Screw and Washer System
  • Model / Serial
    Lot Numbers: 1088402;1088403;1088404;1088405;1088406;1091608;1091646; 1091648;1091628;1088393;1091658; 1088394;1091586; 1088395;1091598;1088396;1088397;1091623; 1088398;1091618; 1088399;1091596; 1091599; 1088401;1091597; 1088337;1091622;1093232;1088985;1091542; 1088986;1091401;1088987;1091581;1091543; 1088989;1091589;1088990;1091614; 1088991;1091402;1091562
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    U.S.
  • Product Description
    SYSTEM 26. Part Numbers: || OS900035-NS; || OS900036-NS; || OS900037-NS; || OS900038-NS; || OS900040-NS; || OS900041-NS; || OS900042-NS; || OS900043-NS; || OS900047-NS; || OS900048-NS; || OS900045-NS; || OS900046-NS; || OS900050-NS; || OS900051-NS; || OS900044-NS; || OS900049-NS; || OS900053-NS; || OS900054-NS; || OS900055-NS; || OS900056-NS; || OS900058-NS; || OS900059-NS; || OS900057-NS.
  • Manufacturer
    ORTHO SOLUTIONS, LTD.

Manufacturer

ORTHO SOLUTIONS, LTD.
  • Manufacturer Address
    ORTHO SOLUTIONS, LTD., West Station Business Park, Spital Road, Maldon United Kingdom
  • Manufacturer Parent Company (2017)
    Ortho Solutions Limited
  • Source
    USFDA