Events

Recall of Device Recall Sterile Distraction Screws of 3 different sizes

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Tedan Surgical Innovations 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
    62899
  • Event Risk Class
    Class 2
  • Event Number
    Z-2385-2012
  • Event Initiated Date
    2012-06-11
  • Event Date Posted
    2012-09-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-07-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112010
  • 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
    This letter is to notify you that several of our sterile screw products are being voluntarily recalled. product sterility may be compromised due to a mechanical failure of the protective packaging tube. tube end plugs may dislodge creating the potential for the screw to come out of the protective tube and then the sharp end of the screw pierce the outer sterile barrier pouch.
  • Action
    The firm, TeDan Surgical Innovations (TSI), sent an "URGENT: Medical Device Recall" letter dated June 11, 2012 to their consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately examine their inventory and quarantine all products subject to recall and return product to TSI. In addition, if they have further distributed this product, identify all customers and notify them of this product recall at once in writing; and complete and return the enclosed Mandatory Response Form as soon as possible and no later than June 25, 2012 via mail: 12675 W. Airport Blvd., Suite 200, Sugar Land, TX 77478; fax: (713) 726-0846 or email: thernandez@tedansurgical.com. If you have any questions, contact the Business Manager at 713-726-0886, Monday thru Friday, from 8am - 5pm or via email at THERNANDEZ@TEDANSURGICAL.COM.

Device

Device Recall Sterile Distraction Screws of 3 different sizes
  • Model / Serial
    Lot numbers: 019715, 019716, 019942, 019943, 019977, 019978, 020102, 020103, 020104, 020105, 020106, 020107, 020108, 020609, 020782,  021539, 021663, 022097, 022098, 022099, 022122, 022123, 022124, 022371, 022372, 022790, 022791, 022792, 022794, 022795, 022796, 022827, 022828, and 023266.
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries of : Australia and Taiwan.
  • Product Description
    Sterile Distraction Screws of 3 different sizes: 12mm, 14mm and 16mm sold under TSI, 3COR, DB Surgical, and American Surgical Products brands and Sterile XL Screws of 7 different sizes: 90mm, 100mm, 110mm, 120mm, 130mm, 140mm, 150mm sold under TSI brand || Sterile Distraction Screws are intended for the distraction in the anterior approach to the cervical spine. Sterile XL Screws are intended for the fixation of the blade to the vertebral body to prohibit drifting in the extreme lateral approach to the lumbar spine.
  • Manufacturer
    Tedan Surgical Innovations Llc

Manufacturer

Tedan Surgical Innovations Llc
  • Manufacturer Address
    Tedan Surgical Innovations Llc, 12615 W Airport Blvd, Ste 200, Sugar Land TX 77478-6203
  • Manufacturer Parent Company (2017)
    Tedan Surgical Innovations L.L.C.
  • Source
    USFDA