Device Recall Gliding Nail Radiolucent Guide instrument set

  • Model / Serial
    Revision A Serial Number: None
  • Product Classification
  • 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
  • 1 Event

Manufacturer

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