Exactech has issued an “URGENT MEDICAL DEVICE CORRECTION” letter to surgeons across the country. Exactech is now expanding the product recall to include all knee and ankle arthroplasty polyethylene inserts packaged in non-conforming bags regardless of label or shelf life. The recall relates too the following:
OPTETRAK OPTETRAK All-polyethylene CR Tibial Components Introduced in the United States in 1994.
OPTETRAK All-polyethylene PS Tibial Components OPTETRAK CR Tibial Inserts
OPTETRAK CR Slope Tibial Inserts
OPTETRAK PS Tibial Inserts
OPTETRAK HI-FLEX PS Tibial Inserts
OPTETRAK Logic (referred to as “Logic” below)
OPTETRAK Logic CR Tibial Inserts Introduced in the United States in 2009.
OPTETRAK Logic CR Slope Tibial Inserts
OPTETRAK Logic CRC Tibial Inserts OPTETRAK Logic PS Tibial Inserts
OPTETRAK Logic PSC Tibial Inserts OPTETRAK Logic CC Tibial Inserts
TRULIANT CR Tibial Inserts. Introduced in the United States in 2017.
TRULIANT CR Slope Tibial Inserts
TRULIANT CRC Tibial Inserts
TRULIANT PS Tibial Inserts
TRULIANT PSC Tibial Inserts
VANTAGE Fixed-Bearing Liner Component. Introduced in the United States in 2016.
For patients who exhibit premature polyethylene wear, the surgeon should consider revision surgery per their clinical judgment. If the surgeon desires to perform an isolated polyethylene exchange, Exactech can provide new polyethylene knee or ankle inserts that are packaged in conforming vacuum bags that contain the specified secondary EVOH oxygen barrier layer.
For more information, and a free evaluation of your legal claim for this recallled product, contact the lawyers at JONES WARD PLC by using the chat function on our website.