Voluntary Class II Recall Exactech Knees and Ankles Issued Feb 2022

The estimated number of knee/ankle implants since 2004 is between 147,000 and 149,000.

Failure Rate according to the manufacturer is 15%, so it is likely much higher.  On the low end, you are looking at 22,000 knees and ankles with defects.

The issue is the polyethylene inserts or liners for both the knees and ankles.  These inserts fit between metal surfaces and degrade.

The manufacturer states that the bags these inserts were housed in were not “up to spec.” and in turn, allowed oxygen into the bags and created degradation/oxidation of the liners.

Injuries include early implant wear, bone loss or necrosis, lysis or disintegration of the bone and the need for early revision.

Basic Numerosity Since 2004:  Optetrak: 60,926 implanted Optetrak Logic: 60,518 implanted, Truliant Knees 24,727 implanted, Vantage Ankle Implants 1,561 implanted. This last one is not on the list below, but should be included.

MDL VENUE HAS NOT YET BEEN SELECTED, BUT THE JPML IS EXPECTED TO HEAR THE MERITS OF THE CASE.

Products included in the Exactech polyethylene joint products recall include:

• OPTETRAK®Unicondylar Tibial Components
• OPTETRAK® All-polyethylene CR Tibial Components
• OPTETRAK® All-polyethylene PS Tibial Components
• OPTETRAK® B-Series Ps Tibial Insert
• OPTETRAK® CC Tibial Inserts
• OPTETRAK® CR Tibial Inserts
• OPTETRAK® CR Slope Tibial Inserts
• OPTETRAK® PS Tibial Inserts
• CUSTOM OPTETRAK® Angled PS Insert
• CUSTOM OPTETRAK® CC Tibial Insert
• OPTETRAK® HI-FLEX® PS Tibial Inserts
• OPTETRAK “MOMB” Non-Mod Molded Insert
• OPTETRAK® RBK PS Tibial Components
• OPTETRAK Logic® CR Tibial Inserts
• 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
• TRULIANT® CR Slope Tibial Inserts
• TRULIANT® CRC Tibial Inserts
• TRULIANT® PS Tibial Inserts
• TRULIANT® PSC Tibial Inserts