Events

Recall of TRIGEN INTERTAN NAIL

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
    68043
  • Event Risk Class
    Class 2
  • Event Number
    Z-1636-2014
  • Event Initiated Date
    2014-04-04
  • Event Date Posted
    2014-05-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-07-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126851
  • 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
    Nail, fixation, bone - Product Code JDS
  • Reason
    A manufacturing error resulted in the set screw being inserted too deep in the affected nails.
  • Action
    The firm initiated the recall via an "Urgent - Product Recall 1st Notification - Urgent" letter and e-mail on 04/04/2014, identifying the product, explaining the problem, and the potential risk associated with using the product. Customers are to inspect their inventory, and locate and quarantine any affected product. Additionally, the Inventory Return Certification form should be completed and returned along with any affected product identified, once a Return Authorization number has been obtained from Smith & Nephew's Safety Affairs Department.

Device

TRIGEN INTERTAN NAIL
  • Model / Serial
    TRIGEN INTERTAN NAIL:  (1) REF 71675201, Lot Numbers: 13LT36305, 13LT36306, 13LT36547, 13LT36548, 13LT37009, 13LT37010, 13MT37347, 13MT37665, 13MT37667, 13MT37668, 14AT38179, 14AT38180, 14AT38181, 14T38182, 14AT38183, 14AT38189, 14AT38190   (2) REF 71675202, Lot Numbers: 13LT36308, 13LT36549, 13LT37011, 13MT37348, 14AT38750  (3) REF 71675203, Lot Numbers: 13KT36106, 13LT36596, 14AT38494  (4) REF 71675204, Lot Numbers: 13LT36597, 13LT37012, 14AT38495, 14AT38660  (5) REF 71675205, Lot Number 13LT36598  (6) REF 71675207, Lot Numbers: 13LT363089, 13LT36310, 13LT36599, 13LT37058, 13LT37059, 13LT37063, 13MT37264, 13MT37265, 13MT37266, 13MT37329, 13MT37349, 13MT37350, 13MT37669, 13MT37671, 13MT37672  (7) REF 71675208, Lot Numbers: 13LT36311, 13LT36312, 13LT36600, 13LT37060, 13LT37061, 13MT37351, 13MT37666, 13MT37963  (8) REF 71675211, Lot Number 13LT36313
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- USA, France, Germany, Sweden, Switzerland, UK, Canada, Australia, Japan, China, India, Dubai, South Africa, South Korea, Mexico, and Venezuela.
  • Product Description
    TRIGEN INTERTAN NAIL: || (1) REF 71675201, 10 MM X 18 CM, 125 degree, || (2) REF 71675202, 11.5 MM X 18 CM, 125 degree, || (3) REF 71675203, 13 MM X 18 CM, 125 degree, || (4) REF 71675204, 10 MM X 20 CM, 125 degree, || (5) REF 71675205, 11.5 MM X 20 CM, 125 degree, || (6) REF 71675207, 10 MM X 18 CM, 130 degree, || (7) REF 71675208, 11.5 MM X 18 CM, 130 degree, || (8) REF 71675211, 11.5 MM X 20 CM, 130 degree, || Smith & Nephew, Inc. Orthopedic fixation device.
  • 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