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Exactech Hips, Knees & Ankles: Big Problems for Patients

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.

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