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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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® 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|
(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:
|South Korea||82 0807202111|