Events

Recall of Device Recall Titanium Surfix Alpha Screws

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Integra LifeSciences Corp..

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
    61125
  • Event Risk Class
    Class 2
  • Event Number
    Z-1147-2012
  • Event Initiated Date
    2011-12-21
  • Event Date Posted
    2012-03-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-02-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107345
  • 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
    Plate, fixation, bone - Product Code HRS
  • Reason
    Manufacturing error. the part number which corresponds to the length dimension of : 14 mm. was incorrectly etched on to screws with the actual measurement of: 12 mm.
  • Action
    Integra contacted the Sales Representatives and All USERS on December 21, 2011, with a 'SUBJECT: MEDICAL DEVICE RECALL' letter. The letter was sent via FedEx and/or E-mail. The letter describes the product, problem, and the actions to be taken by the customers and the firm. The customers are instructed to immediately examine their inventories for the presence of the recalled product, and complete and return the attached, MEDICAL DEVICE RECALL ACKNOWLEDGMENT AND RETURN FORM via E-mail or FAX #1-609-0750-7999. Any questions concerning the recall document are to be addressed to the customers' regional managers or to the E-mail address and/or telephone number provided on the recall notification.

Device

Device Recall Titanium Surfix Alpha Screws
  • Model / Serial
    Model #295214S, Part #295214SND, Batch #EGH9
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution, USA - including the states of OH, FL, WI, CT, OK, TN, OR, ID, CA, PA, MD, VA, FL, MS, NJ, LA, IA, GA, AL, MA, NY, MN, TN, IL, AR, NE, AZ, MI, WA, OR, NC, KY, MO, UT, NV, IN, SC, CO and the countries of the United Kingdom, France, Switzerland, and Austria.
  • Product Description
    Titanium SURFIX ALPHA SCREWS, a component of the Newdeal Hallu Lock Plate System. Surfix Alpha Variable angle locking system exists in different diameters and lengths. The product can be sold as a replenishment part individually packaged sterile, or as one (1) unit which is kitted within an instrumentation tray at which point, the product is non-sterile until the tray in which it is kitted is sterilized a the designated facility. The product is indicated for use in fixation of fractures, osteotomies or arthrodesis of the first metatarso-phalangeal joint.
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.