Events

Recall of DRLock Bone Fixation Plate systems

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by OrthoHelix Surgical Designs Inc.

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
    44883
  • Event Risk Class
    Class 2
  • Event Number
    Z-0136-2008
  • Event Initiated Date
    2007-09-04
  • Event Date Posted
    2007-12-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-05-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64471
  • 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
    Bone Fixation Plate - Product Code HRS
  • Reason
    Seat/fit problems: the heads of the distal screws/pegs rest above the surface of the distal plate after the screws/pegs are fully tightened.
  • Action
    On 9/4/2007, OrthoHelix mailed an Important Recall Notification letters via certified mail to all direct accounts. The notification instructed all accounts to examine their inventory and return all recalled product, identified within the notification, to OrthoHelix for replacement.

Device

DRLock Bone Fixation Plate systems
  • Model / Serial
    LOT NUMBERS: R330, R342, and R343 for styles DRV-002-0R, DRV-002-0L, DRV-002-1R, DRV-002-1L of Bone Fixation Plates-----ALL LOTS of Distal Screws with the following part numbers : DRV-021-24-10; DRV-021-24-12; DRV-021-24-14; DRV-021-24-16; DRV-021-24-18; DRV-021-24-20; DRV-021-24-22; & DRV-021-24-24.-----ALL LOTS of Distal Pegs with the following part numbers : DRV-121-20-10; DRV-121-20-12; DRV-121-20-14; DRV-121-20-16; DRV-121-20-18; DRV-121-20-20; DRV-121-20-22; & DRV-121-20-24.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide; including states of IL, CA, VA, TX, MD, UT, GA, CO, NJ, OH, & WI.
  • Product Description
    DRL System Trays comprised of DRLock Bone Fixation Plates, Pegs, and Screw Systems: Four Plate Styles include: Part Numbers: DRV-002-0L Fixed Short Left Plate, DRV-002-0R , Fixed Short Right Plate, DRV-002-1L, Fixed Standard Left Plate, and DRV-002-1R, Fixed Standard Right Plate; Distal Screw Part Numbers: DRV-021-24-10, -12, -14, -16, -18, -20, -22 and -24; Distal Peg Part Number: DRV-121-20-10, -12, -14, -16, -18, -20, -22, and -24; All screw caddies and any distal screw and peg inventory not yet added to screw caddies, Ortho Helix Surgical Designs, Inc., Akron, OH
  • Manufacturer
    OrthoHelix Surgical Designs Inc

Manufacturer

OrthoHelix Surgical Designs Inc
  • Manufacturer Address
    OrthoHelix Surgical Designs Inc, 1815 W Market St Ste 205, Akron OH 44313-7018
  • Source
    USFDA