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US Exactech Recall Information

Knee and Ankle Polyethylene

This is to inform you of recent observations made by Exactech regarding the clinical performance of our Knee and Ankle polyethylene inserts.

The following products are affected:

Scroll right to view the full table on mobile devices.

Product LineSpecific Brand NameTotal Units Sold
Globally
(2004-2.22.2022)
OPTETRAK® All-polyethylene Tibial Components (TKR)5078
200-11-XXOPTETRAK® All-polyethylene CR Tibial Components1
200-12-XXOPTETRAK® All-polyethylene CR Tibial Components36
200-13-XXOPTETRAK® All-polyethylene CR Tibial Components117
200-14-XXOPTETRAK® All-polyethylene CR Tibial Components79
200-15-XXOPTETRAK® All-polyethylene CR Tibial Components38
200-16-XXOPTETRAK® All-polyethylene CR Tibial Components8
204-11-XXOPTETRAK® All-polyethylene PS Tibial Components1097
204-12-XXOPTETRAK® All-polyethylene PS Tibial Components1834
204-13-XXOPTETRAK® All-polyethylene PS Tibial Components1277
204-14-XXOPTETRAK® All-polyethylene PS Tibial Components528
204-15-XXOPTETRAK® All-polyethylene PS Tibial Components61
204-16-XXOPTETRAK® All-polyethylene PS Tibial Components2
OPTETRAK® All-polyethylene Tibial Components (PKR)3428
252-12-XXOPTETRAK® All-polyethylene UNI Tibial Components1163
252-13-XXOPTETRAK® All-polyethylene UNI Tibial Components1198
252-22-XXOPTETRAK® All-polyethylene UNI Tibial Components524
252-23-XXOPTETRAK® All-polyethylene UNI Tibial Components543
OPTETRAK® Tibial Inserts (TKR)218944
200-21-XXOPTETRAK® CR TIBIAL INSERT5803
200-22-XXOPTETRAK® CR TIBIAL INSERT24356
200-23-XXOPTETRAK® CR TIBIAL INSERT20527
200-24-XXOPTETRAK® CR TIBIAL INSERT9570
200-25-XXOPTETRAK® CR TIBIAL INSERT3032
200-26-XXOPTETRAK® CR TIBIAL INSERT270
200-50-XXOPTETRAK® CR TIBIAL INSERT161
200-51-XXOPTETRAK® CR TIBIAL INSERT4102
200-56-XXOPTETRAK® CR TIBIAL SLOPE + INSERT67
200-57-XXOPTETRAK® CR TIBIAL SLOPE ++ INSERT93
200-61-XXOPTETRAK® CR TIBIAL SLOPE + INSERT176
200-62-XXOPTETRAK® CR TIBIAL SLOPE + INSERT1012
200-63-XXOPTETRAK® CR TIBIAL SLOPE + INSERT1047
200-64-XXOPTETRAK® CR TIBIAL SLOPE + INSERT623
200-65-XXOPTETRAK® CR TIBIAL SLOPE + INSERT204
200-71-XXOPTETRAK® CR TIBIAL SLOPE ++ INSERT148
200-72-XXOPTETRAK® CR TIBIAL SLOPE ++ INSERT906
200-73-XXOPTETRAK® CR TIBIAL SLOPE ++ INSERT1030
200-74-XXOPTETRAK® CR TIBIAL SLOPE ++ INSERT563
200-75-XXOPTETRAK® CR TIBIAL SLOPE ++ INSERT218
204-21-XXOPTETRAK® PS TIBIAL INSERTS10048
204-22-XXOPTETRAK® PS TIBIAL INSERTS38886
204-23-XXOPTETRAK® PS TIBIAL INSERTS32689
204-24-XXOPTETRAK® PS TIBIAL INSERTS14623
204-25-XXOPTETRAK® PS TIBIAL INSERTS4748
204-26-XXOPTETRAK® PS TIBIAL INSERTS611
204-50-XXOPTETRAK® PS TIBIAL INSERTS392
204-51-XXOPTETRAK® PS TIBIAL INSERTS5516
204-91-XXOPTETRAK "MOMB" NON-MOD MOLDED INSERT282
204-92-XXOPTETRAK "MOMB" NON-MOD MOLDED INSERT864
204-93-XXOPTETRAK "MOMB" NON-MOD MOLDED INSERT1167
204-94-XXOPTETRAK "MOMB" NON-MOD MOLDED INSERT668
204-95-XXOPTETRAK "MOMB" NON-MOD MOLDED INSERT176
208-21-XXOPTETRAK® CC TIBIAL INSERT2996
208-22-XXOPTETRAK® CC TIBIAL INSERT10026
208-23-XXOPTETRAK® CC TIBIAL INSERT9143
208-24-XXOPTETRAK® CC TIBIAL INSERT5175
208-25-XXOPTETRAK® CC TIBIAL INSERT1824
208-51-XXOPTETRAK® CC TIBIAL INSERT1136
224-21-XXOPTETRAK® B-SERIES PS TIBIAL INSERT547
224-22-XXOPTETRAK® B-SERIES PS TIBIAL INSERT1719
224-23-XXOPTETRAK® B-SERIES PS TIBIAL INSERT1347
224-24-XXOPTETRAK® B-SERIES PS TIBIAL INSERT453
OPTETRAK® HI-FLEX® Polyethylene Tibial Inserts (TKR)51913
244-20-XXOPTETRAK® HI-FLEX® PS Polyethylene Tibial Inserts226
244-21-XXOPTETRAK® HI-FLEX® PS Polyethylene Tibial Inserts6787
244-22-XXOPTETRAK® HI-FLEX® PS Polyethylene Tibial Inserts18921
244-23-XXOPTETRAK® HI-FLEX® PS Polyethylene Tibial Inserts15578
244-24-XXOPTETRAK® HI-FLEX® PS Polyethylene Tibial Inserts7662
244-25-XXOPTETRAK® HI-FLEX® PS Polyethylene Tibial Inserts2739
ARTHROFOCUS® Polyethylene Tibial Inserts (TKR)12
256-12-XXARTHROFOCUS® Polyethylene Tibial Inserts6
256-13-XXARTHROFOCUS® Polyethylene Tibial Inserts6
OPTETRAK® Custom Polyethylene Tibial Inserts (TKR)41
900-06-XXCUSTOM OPTETRAK® ANGLED PS INSERT6
900-08-XXCUSTOM OPTETRAK® ANGLED PS INSERT6
900-23-XXCUSTOM OPTETRAK® CC TIBIAL INSERT21
900-30-XXCUSTOM OPTETRAK® CC TIBIAL INSERT4
900-33-XXCUSTOM OPTETRAK® CC INSERT4
OPTETRAK® LOGIC® Polyethylene Tibial Inserts (TKR)127998
02-012-35-XXXXOPTETRAK® Logic PS Tibial Inserts80506
02-012-44-XXXXOPTETRAK® Logic PSC Tibial Inserts19323
02-012-47-XXXXOPTETRAK® Logic CR Tibial Inserts9139
02-012-48-XXXXOPTETRAK® Logic CR Slope + Tibial Inserts3083
02-012-49-XXXXOPTETRAK® Logic CR Slope ++ Tibial Inserts2853
02-012-51-XXXXOPTETRAK® Logic CRC Tibial Inserts10291
02-012-65-XXXXOPTETRAK® Logic CC Tibial Inserts2803
OPTETRAK® RBK® Polyethylene Tibial Inserts (TKR)33393
264-21-XXOPTETRAK® RBK PS Tibial Components2938
264-22-XXOPTETRAK® RBK PS Tibial Components10994
264-23-XXOPTETRAK® RBK PS Tibial Components11560
264-24-XXOPTETRAK® RBK PS Tibial Components5738
264-25-XXOPTETRAK® RBK PS Tibial Components2163
TRULIANT® Tibial Inserts (TKR)38075
02-022-35-XXXXTRULIANT® PS Tibial Inserts20913
02-022-44-XXXXTRULIANT® PSC Tibial Inserts6519
02-022-47-XXXXTRULIANT® CR Tibial Inserts3095
02-022-48-XXXXTRULIANT® CR Slope + Tibial Inserts504
02-022-49-XXXXTRULIANT® CR Slope ++ Tibial Inserts335
02-022-51-XXXXTRULIANT® CRC Tibial Inserts6709
OPTETRAK® Logic RBK Tibial Components (TKR)10616
02-012-38-XXXXOPTETRAK® Logic RBK PS Tibial Components10616
Vantage® Fixed-Bearing Polyethylene Liner Component (TAR)2959
350-21-XXVantage® Fixed-Bearing Polyethylene Liner Component1422
350-22-XXVantage® Fixed-Bearing Polyethylene Liner Component1537
Vantage® Mobile-Bearing Polyethylene Liner Component (TAR)761
350-41-XXVantage® Mobile-Bearing Polyethylene Liner Component352
350-42-XXVantage® Mobile-Bearing Polyethylene Liner Component409

Exactech Knee & Ankle Polyethylene Patients: What to do

Please use the following link to see if your hip liner is affected by this recall (you will need your serial number):

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.

Patient CountryEmailCalling from outside of the countryCalling from inside the country
United States(888) 912-0403888-912-0403
Australiaexactech.recall@crawco.com.au+61 18005921900283112724
Franceexactech.recall@crawco.be+32 80026327N/A
Germanyexactech.recall@crawco.de49 (211) 54012549N/A
Italyexactech.recall@crawco.it+39 02007041150200704115
Japanexactech.recall@crawford.co.jp+81 800000150708000001507
South Koreaexactech.recall@dasca.com+82 0807202111807202111
Spainexactech.recall@crawford-spain.com+34 900999585900999585
Singaporeexactech.recall@crawford.asia+65 180032114218003211421
United Kingdomexactech.recall@crawco.co.uk01908 99116301908 991163
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