Events

Recall of Device Recall PS Tibial Insert

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ortho Development Corporation.

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
    68898
  • Event Risk Class
    Class 2
  • Event Number
    Z-2255-2014
  • Event Initiated Date
    2014-07-11
  • Event Date Posted
    2014-08-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-10-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128977
  • 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, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
  • Reason
    Ortho development is recalling various pivot bipolar cup, patella, ps tibial insert, uc tibila insert, and ck tibil insert because the foil pouches did not properly seal, allowing air to seep back into the pouch after sealing which increases the risk that the material properties of the implant would be substantially degraded due to oxidation.
  • Action
    Ortho Development notified all affected consignees/distributors of the recall via email on July 11, 2014 which included a list of the affected product (part numbers, lot numbers and quantities) under their control. An RMA number and return shipping label were also included with the email. Emails were followed up with phone calls to verify receipt of the notification.

Device

Device Recall PS Tibial Insert
  • Model / Serial
    PS Tibial Insert Size 3 8mm,Part 163-1308,Lot A135943,PS Tibial Insert Size 3 9mm,Part 163-1309,Lot A136492,PS Tibial Insert Size 3 12mm,Part 163-1312,Lot A136453,PS Tibial Insert Size 4 7mm,Part 163-1407,Lot A135945,PS Tibial Insert Size 4 7mm,Part 163-1407,Lot A136454,PS Tibial Insert Size 5 9mm,Part 163-1509,Lot A135827,
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - US Nationwide and the country of Japan. No military/govt/VA consignees.
  • Product Description
    PS Tibial Insert, REF 163-1XXX || Product Usage: || UHMWPE component used in TKA procedures to serve as a tibial bearing surface for articulation with the femoral component
  • Manufacturer
    Ortho Development Corporation

Manufacturer

Ortho Development Corporation
  • Manufacturer Address
    Ortho Development Corporation, 12187 Business Park Dr, Draper UT 84020-8663
  • Manufacturer Parent Company (2017)
    Ortho Development Corporation
  • Source
    USFDA