Events

Recall of Torque Limiting Handle

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

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
    33713
  • Event Risk Class
    Class 2
  • Event Number
    Z-0183-06
  • Event Initiated Date
    2005-10-04
  • Event Date Posted
    2005-11-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-02-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42320
  • 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
    The torque value of the device may increase over time. the increase could exceed the tolerance specification.
  • Action
    The recalling firm sent consignees a technical bulletin letter, dated 4/4/05.

Device

Torque Limiting Handle
  • Model / Serial
    The Torque handles contain serial #1 through serial #76 and are part number 10-40-0122 contained in the Coral Lumbar System, Lot W1902 and W1558.
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    The product was distributed to AL, AR, CA, FL, ID, IN, KS, LA, MO, NJ, OH, PA, TX, UT, WA, WV.
  • Product Description
    Torque Limiting Handle, model # 10-40-0122, a component of the Lumbar Coral System (Pedicle Screw System).
  • Manufacturer
    Theken Spine LLC

Manufacturer

Theken Spine LLC
  • Manufacturer Address
    Theken Spine LLC, 283 E Waterloo Rd, Akron OH 44319-1238
  • Source
    USFDA