Devices

Device Recall Apelo Modular Screwdriver for Apelo Pedicle Screw System

  • Modèle / numéro de série
    PN# 70175-001 CAT#2006-41-0000 Lot # 00686
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    USA Distribution to the state of Florida only.
  • Description du dispositif
    Apelo Modular Screwdriver labeled in part: "APELO PEDICLE SCREW SYSTEM***Modular Screwdriver***Atlas Spine, Inc.***www.AtlasSpine.com*** 1555 Jupiter Park Drive #4***Jupiter, Florida 33458***561-741-1108***Tissue Sleeve***MFG Date: XX/XX/XXXX***Lot #: XXXX***Weldment***MFG Date: 03/23/2009***Sleeve Assembly***MFG Date: XX/XX/XXXX***Lot #: XXXX***Qty: 1 Rx Only***Non-Sterile. Sterilize Prior to Use*** Rev. A***. The Modular Screwdriver is used to insert modular pedicle screw implants which are part of the Apelo System.
  • Manufacturer
    Atlas Spine, Inc.
  • 1 Event

Fabricant

Atlas Spine, Inc.
  • Adresse du fabricant
    Atlas Spine, Inc., 1555 Jupiter Park Dr Ste 4, Jupiter FL 33458-8085
  • Société-mère du fabricant (2017)
    Atlas Spine Inc.
  • Source
    USFDA