Events

Recall of Finger Joint Implants, Silicone || Models TRL-10 and TRL-20

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Avanta Orthopaedics, 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
    25577
  • Event Risk Class
    Class 3
  • Event Number
    Z-0710-03
  • Event Initiated Date
    2003-01-24
  • Event Date Posted
    2003-04-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-12-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26086
  • 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
    Prosthesis, Wrist, Carpal Trapezium - Product Code KYI
  • Reason
    Wrong silicone elastomer used in construction.
  • Action
    Recall was initiated by telephone on 1/24/2003. All customers responded by 1/28/2003. All units have been accounted for. The units have been returned. The recall is complete.

Device

Finger Joint Implants, Silicone || Models TRL-10 and TRL-20
  • Model / Serial
    TRL-10, Lot 45275002, 13 units shipped TRL-20, Lot 45186001, 30 units shipped
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    States of CA and UT and to France.
  • Product Description
    Finger Joint Implants, Silicone || Models TRL-10 and TRL-20
  • Manufacturer
    Avanta Orthopaedics, Inc.

Manufacturer

Avanta Orthopaedics, Inc.
  • Manufacturer Address
    Avanta Orthopaedics, Inc., 9369 Carroll Park Drive Ste A, San Diego CA 92121
  • Source
    USFDA