Events

Recall of Device Recall Gliding Nail Radiolucent Guide instrument set

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

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
    35054
  • Event Risk Class
    Class 2
  • Event Number
    Z-0928-06
  • Event Initiated Date
    2006-02-22
  • Event Date Posted
    2006-06-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-12-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45198
  • 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
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component - Product Code KTT
  • Reason
    Plus usa has been informed by plus ag that the accuracy of the instrument set may be affected in some cases. it is possible that in rare cases where patients have sclerotic (excessively hardened or firm) bone, that components may deform under application of force as the surgeon attempts to penetrate this bone with the instruments.
  • Action
    There were a total of five (5) radiolucent guide instrument sets affected by the recall (imported to the U.S. between 1/23/2006 and 1/30/2006). The firm telephoned agents beginning February 22, 2006, requesting return of the devices. Returned Material Authorizations have been issued (March, 2006) for consigned inventory in the field with instructions given to remove and return affected units immediately. All returns to PLUS Orthopedics USA have been appropriately quarantined and segregated to prevent unintended use or shipment.

Device

Device Recall Gliding Nail Radiolucent Guide instrument set
  • Model / Serial
    Revision A Serial Number: None
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    There were a total of five (5) radiolucent guide instrument sets affected by the recall (imported to the U.S. between 1/23/2006 and 1/30/2006). The 5 sets were distributed in the following states: 1) California, 2) Idaho, and 3) New York.
  • Product Description
    Model Number: GNRADIOLUCENTGUIDE (Gliding Nail Radiolucent Guide), instrument set that contains one unit of each of the following instrument: || 1130020-A: GNp Carbon Targeting Handle || 1130021-A: GN Adapter Screw for Handle SW 10 || 1130022-A: GN Targeting Guide Carbon 125¿ || 1130023-A: GN Targeting Guide Carbon 135¿ || 1130060-A: GNp Drill Guide Locking No. 3 || 1133158-A: GN Centering Sleeve New Guide || Description: Surgical instruments comprising the Gliding Nail Radiolucent Guide, supplied unsterile for use in reusable sterilization trays.
  • Manufacturer
    Plus Orthopedics USA

Manufacturer

Plus Orthopedics USA
  • Manufacturer Address
    Plus Orthopedics USA, 10188 Telesis Ct, San Diego CA 92121-4779
  • Source
    USFDA