Events

Recall of Device Recall 3.5mm Locking Cortical Bone Screw, T15 Hexalobe, Self Tapping, 20mm

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

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
    67302
  • Event Risk Class
    Class 2
  • Event Number
    Z-0934-2014
  • Event Initiated Date
    2014-01-08
  • Event Date Posted
    2014-02-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-04-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125200
  • 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
    Orthopediatrics has initiated a voluntary recall of part # 00-0903-2620, 3.5mm locking cortical screw, lot # 009sv because the device within the package may be incorrect. these packages incorrectly contain a 3.5mm non locking cortical screw # 00-1050-3524.
  • Action
    Orthopediatrics Corporation has requested sales representatives and distributors who have been identified via shipping records as having the possibility of having received one or more discrepant devices affected by this Recall were requested to quarantine the devices identified in this Recall by telephone on January 8, 2014. The decision to Recall these devices was made and a formal written Recall Notice sent to the consignees via email on January 13, 2014. Notification will not be sent to hospitals at this time provided that all devices are retrieved or accounted for within 60 days of the initiation of recall. Hospitals will be notified on an as needed basis if OrthoPediatrics determines that all recalled devices have not been recovered or accounted for, and that contacting the hospitals involved will expedite the recall efforts. All discrepant devices subject to this voluntary Recall are planned to be returned from distribution to OrthoPediatrics Corp. in Warsaw, Indiana and maintained in quarantine. All remaining unshipped devices from these lots have been placed in quarantine at OrthoPediatrics Corp. All quarantined devices at OrthoPediatrics will be inspected and repackaged to correct the mislabeling per normal documented procedures. Objective evidence will be maintained of the rework of the devices. For questions regarding this recall call 574-268-6379.

Device

Device Recall 3.5mm Locking Cortical Bone Screw, T15 Hexalobe, Self Tapping, 20mm
  • Model / Serial
    Lot 009SV
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA including OK, KY, FL, LA, OH, CO, MO, MN and Internationally to Ireland, Saudi Arabia, Italy, Turkey, South Africa, and Germany.
  • Product Description
    3.5mm Locking Cortical Bone Screw, T15 Hexalobe, Self Tapping, 20mm || Part No. 00-0903-2620 || OrthoPediatrics Pediloc" Tibia Plates are indicated for fractures, osteotomies, and non-unions of the pediatric and small stature adult tibia. The subject recalled device is a Bone Screw designed for use with this system.
  • Manufacturer
    OrthoPediatrics Corp

Manufacturer

OrthoPediatrics Corp
  • Manufacturer Address
    OrthoPediatrics Corp, 2850 Frontier Dr, Warsaw IN 46582-7001
  • Manufacturer Parent Company (2017)
    Orthopediatrics Corp
  • Source
    USFDA