Events

Recall of Device Recall TRIGEN (TM) LP SCREW, 4.5 MM X 37.5 MM

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Smith & Nephew Inc.

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
    64669
  • Event Risk Class
    Class 2
  • Event Number
    Z-1132-2013
  • Event Initiated Date
    2013-03-06
  • Event Date Posted
    2013-04-17
  • Event Status
    Completed
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116740
  • 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
    Rod, fixation, intramedullary and accessories - Product Code HSB
  • Reason
    One batch of 4.5 mm diameter trigen low-profile bone screws were incorrectly anodized with a gold coating (indicating a 5 mm diameter) instead of a gray coating (indicating a 4.5 mm diameter).
  • Action
    Smith & Nephew sent an Urgent Product Recall Notification letter dated March 6, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to cease use and distribution of the affected product and quarantine for return. Non-responding consignees were notified again on March 15, 2013, by email. Surgeons were to be notified by letter beginning on March 20, 2013. For questions regarding this recall call 978-749-1330.

Device

Device Recall TRIGEN (TM) LP SCREW, 4.5 MM X 37.5 MM
  • Model / Serial
    Lot Number 12FM12182
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including CA, FL, GA, MA, MI, NC, SC, OH, and MO.
  • Product Description
    TRIGEN (TM) L-P SCREW, 4.5 MM X 37.5 MM, TI-6AL-4V, QTY: (1), STERILE R, REF 71645437, Smith & Nephew, Inc. Memphis, TN 38116 USA || orthopedic surgery
  • Manufacturer
    Smith & Nephew Inc

Manufacturer

Smith & Nephew Inc
  • Manufacturer Address
    Smith & Nephew Inc, 1450 E. Brooks Rd, Memphis TN 38116
  • Manufacturer Parent Company (2017)
    Smith & Nephew plc
  • Source
    USFDA