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US Exactech Recall Information

Polyethylene

This is to inform you of recent observations made regarding the clinical performance of Exactech polyethylene inserts. This communication relates to Exactech knee and ankle polyethylene liners sold in the United States. The product-specific information is listed in the links below.

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System
Component Description
Marketing Dates
Implanted units in US since 2004
Exactech Partial Knee Replacement Systems
OPTETRAK® OPTETRAK® Unicondylar Tibial Components Introduced in the United States in 2004 680
Exactech Total Knee Replacement Systems
OPTETRAK®

 

OPTETRAK® All-polyethylene CR Tibial Components Introduced in the United States in 1994. 60,246
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®

(referred to as “Logic” below)

OPTETRAK Logic® CR Tibial Inserts Introduced in the United States in 2010. 60,518
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® TRULIANT® CR Tibial Inserts Introduced in the United States in 2017. 24,727
TRULIANT® CR Slope Tibial Inserts
TRULIANT® CRC Tibial Inserts
TRULIANT® PS Tibial Inserts
TRULIANT® PSC Tibial Inserts
Exactech Total Ankle Replacement Systems
VANTAGE® VANTAGE® Fixed-Bearing Liner Component Introduced in the United States in 2016. 1,561

Exactech Polyethylene Patients: What to do

Exactech has established a telephone hotline to provide patients with additional information. Please call (888) 892-5635 to hear a pre-recorded message of frequently asked questions. You may also request a call back from a Healthcare Professional to answer additional questions you may have.

Exactech is committed to addressing recall-related out-of-pocket expenses, and has partnered with Broadspire, a Third Party Administrator, to manage the claims reimbursement process Please contact the Exactech-Broadspire Helpline at (888) 912-0403 to initiate the claims process. Please note that when you call the helpline, you will be asked to verify that you have received an Exactech implant included in the recall.  In order to verify that you do have an Exactech implant, you will be asked the following information:

  • Date of joint replacement surgery
  • Surgeon performing your joint replacement surgery
  • Serial number of your implant (this number can be found in your medical records)-We understand that you may not have this information available. If you do not, we will still initiate a claim, and will work with your surgeon to obtain. 

During the call, you will be assigned a claim number and will receive instructions on how to submit claims for reimbursement.

After you have initiated a claim, please submit any additional requests for reimbursement for out-of-pocket expenses and costs you incur related to evaluation and treatment to Broadspire, using the claim number they have assigned to you.

Claims will be processed on a case-by-case basis.  Please note the following steps in the claims management process:
Call the Exactech-Broadspire Helpline in your country: 

CountryTelephone Number
Australia61 1800592190
France32 80026327
Italy39 0200704115
Japan81 8000001507
South Korea82 0807202111
Spain32 80026327
United States888-912-0403
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