« All FAQ About Exactech Recalls

Which Devices Did Exactech Recall?

Exactech identified the several devices it manufactured and sold from 2004 through 2022 as containing materials that may be defective and could cause them to fail. The following knee, ankle, and hip replacements are recalled:

  • OPTETRAK Partial & Total Knee Replacements:
    • All-polyethylene CR Tibial Components
    • All-polyethylene PS Tibial Components
    • B-Series Ps Tibial Insert
    • CC Tibial Inserts
    • CR Tibial Inserts
    • CR Slope Tibial Inserts
    • PS Tibial Inserts
    • CUSTOM OPTETRAK Angled PS Insert
    • CUSTOM OPTETRAK CC Tibial Insert
    • HI-FLEX® PS Tibial Inserts
    • HI-FLEX® PS Tibial Inserts
    • RBK PS Tibial Components
  • Exactech OPTETRAK Logic Total Knee Replacements:
    • CR Tibial Inserts
    • CR Slope Tibial Inserts
    • CRC Tibial Inserts
    • PS Tibial Inserts
    • PSC Tibial Inserts
    • CC Tibial Inserts
  • Exactech Truliant Logic Total Knee Replacements:
    • CR Tibial Inserts
    • CR Slope Tibial Inserts
    • CRC Tibial Inserts
    • PS Tibial Inserts
    • PSC Tibial Inserts
  • Exactech Vantage Total Ankle Replacement:
    • Fixed-Bearing Liner Component
  • Total Hip Replacement Liner:
    • Exactech Connexion GXL polyethylene liner

If you are unsure which component you have, you may request this information from your surgeon. Specifically, ask for the Product ID Sticker and operative report.

Notice of a Class II recall of the knee and ankle products was issued by Exactech on February 7, 2022. Surgeons, hospitals and health care professionals received the notice. It informed them of early deterioration of the polyethylene components that may require surgical removal of defective devices. A separate letter went out to surgeons in June 2021, indicating the Connexion GXL acetabular liner may fail early.

Related Questions:

What prompted a recall?

Exactech claims it discovered (through testing) that polyethylene components used in the total ankle, hip, and knee replacement systems were packaged and stored in “non-conforming” vacuum bags. The purpose of the bags was to limit exposure of the polyethylene or plastic components while in storage... read more?

What if you received an Exactech knee, ankle or hip replacement?

The notice sent to surgeons recommends against removing an Exactech device absent evidence of its failure as long as it functions properly and is not causing pain or discomfort to a recipient. The company advised physicians company to monitor patients who... read more?