Events

Recall of Device Recall SpineTech

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sulzer Spine-Tech.

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
    25421
  • Event Risk Class
    Class 2
  • Event Number
    Z-0559-03
  • Event Initiated Date
    2003-01-17
  • Event Date Posted
    2003-02-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-05-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25803
  • 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
    Orthopedic Manual Surgical Instrument - Product Code LXH
  • Reason
    With 14 units distributed, there have been 10 complaints of the product having a twisted or broken tip.
  • Action
    The firm sent a letter, dated January 17, 2003, which requested that the consignees return the product.

Device

Device Recall SpineTech
  • Model / Serial
    Lot numbers P010900 and P010957
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    The instruments to be recalled are at 2 consignees in California and Mississippi. 21 units are with the firm''s sales representatives.
  • Product Description
    Spine-Tech Ancillary Discectomy Instrument (Box Curette), Catalog Number 07.00254.001, in Spine-Tech Ancillary Discectomy Instrument Set, Catalog Number 07.00316.001.
  • Manufacturer
    Sulzer Spine-Tech

Manufacturer

Sulzer Spine-Tech
  • Manufacturer Address
    Sulzer Spine-Tech, 7375 Bush Lake Road, Minneapolis MN 55439-2027
  • Source
    USFDA