Introduction
Here at the Michael Brady Lynch Firm, we have been handling pharmaceutical drug and device litigation cases for over a decade. When a device gets recalled, there are major legal implications surrounding the circumstances of the recall. Some of these are things such as product defects, design defects, failure to warn, and improper labeling. Exactech is a knee replacement implant system that was recalled due to “the presence of polyethylene defect found in an insert attached to the device.”
Recall
There are multiple different knee and ankle polyethylene inserts that have been recalled due to product failure. Some of the names of the system include Optetrak, Truliant, Vantage, and Logic.
The recall occurred because “the devices… Out of specifications and packaging did not adequately protect the inserts from oxygen exposure.” the components that were recalled are ultra-high molecular weight polyethylene knee and ankle inserts that go between the metal components in the knee and ankle replacements to cushion joints. The recall extends to all of the ones for the knees and ankles listed above, “regardless of label or shelf life,” which would mean that the year of packaging or creation is insignificant to the actual recall.
Claims and Criteria
The claim being verbalized against the company is that they did not design the devices in a reasonable manner, which is a product defect and manufacturer design defect. The qualifying criteria is currently a person who has received a knee replacement and is experiencing some of the symptoms, such as severe pain and distress, in the joint or knee that the replacement surgery was performed.
Michael Brady Lynch Firm
If you or a loved one have been injured by the Exactech knee replacement, and if you have a device currently in your knee that is causing you pain and distress that may lead to revision surgery, please give us a call here at the Michael Brady Lynch firm. Our number is 888-585-5970.
Date: April 22, 2022
Author: Brandon Salter
https://www.exac.com/medical-professionals/recall-information/
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?start_search=1&event_id=88126&productdescriptiontxt=&productcode=&rootCauseText=¢erclassificationtypetext=&recallnumber=&postdatefrom=&postdateto=&productshortreasontxt=&firmlegalnam=&PMA_510K_Num=&pnumber=&knumber=
https://www.drugwatch.com/news/2022/02/23/exactech-recalls-knee-ankle-replacement-parts-may-fail-early/
https://www.drugwatch.com/news/2022/02/23/exactech-recalls-knee-ankle-replacement-parts-may-fail-early/