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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| Product Line | Specific Brand Name | Total Units Sold Globally (2004-2.22.2022) |
|---|---|---|
| OPTETRAK® All-polyethylene Tibial Components (TKR) | 5078 | |
| 200-11-XX | OPTETRAK® All-polyethylene CR Tibial Components | 1 |
| 200-12-XX | OPTETRAK® All-polyethylene CR Tibial Components | 36 |
| 200-13-XX | OPTETRAK® All-polyethylene CR Tibial Components | 117 |
| 200-14-XX | OPTETRAK® All-polyethylene CR Tibial Components | 79 |
| 200-15-XX | OPTETRAK® All-polyethylene CR Tibial Components | 38 |
| 200-16-XX | OPTETRAK® All-polyethylene CR Tibial Components | 8 |
| 204-11-XX | OPTETRAK® All-polyethylene PS Tibial Components | 1097 |
| 204-12-XX | OPTETRAK® All-polyethylene PS Tibial Components | 1834 |
| 204-13-XX | OPTETRAK® All-polyethylene PS Tibial Components | 1277 |
| 204-14-XX | OPTETRAK® All-polyethylene PS Tibial Components | 528 |
| 204-15-XX | OPTETRAK® All-polyethylene PS Tibial Components | 61 |
| 204-16-XX | OPTETRAK® All-polyethylene PS Tibial Components | 2 |
| OPTETRAK® All-polyethylene Tibial Components (PKR) | 3428 | |
| 252-12-XX | OPTETRAK® All-polyethylene UNI Tibial Components | 1163 |
| 252-13-XX | OPTETRAK® All-polyethylene UNI Tibial Components | 1198 |
| 252-22-XX | OPTETRAK® All-polyethylene UNI Tibial Components | 524 |
| 252-23-XX | OPTETRAK® All-polyethylene UNI Tibial Components | 543 |
| OPTETRAK® Tibial Inserts (TKR) | 218944 | |
| 200-21-XX | OPTETRAK® CR TIBIAL INSERT | 5803 |
| 200-22-XX | OPTETRAK® CR TIBIAL INSERT | 24356 |
| 200-23-XX | OPTETRAK® CR TIBIAL INSERT | 20527 |
| 200-24-XX | OPTETRAK® CR TIBIAL INSERT | 9570 |
| 200-25-XX | OPTETRAK® CR TIBIAL INSERT | 3032 |
| 200-26-XX | OPTETRAK® CR TIBIAL INSERT | 270 |
| 200-50-XX | OPTETRAK® CR TIBIAL INSERT | 161 |
| 200-51-XX | OPTETRAK® CR TIBIAL INSERT | 4102 |
| 200-56-XX | OPTETRAK® CR TIBIAL SLOPE + INSERT | 67 |
| 200-57-XX | OPTETRAK® CR TIBIAL SLOPE ++ INSERT | 93 |
| 200-61-XX | OPTETRAK® CR TIBIAL SLOPE + INSERT | 176 |
| 200-62-XX | OPTETRAK® CR TIBIAL SLOPE + INSERT | 1012 |
| 200-63-XX | OPTETRAK® CR TIBIAL SLOPE + INSERT | 1047 |
| 200-64-XX | OPTETRAK® CR TIBIAL SLOPE + INSERT | 623 |
| 200-65-XX | OPTETRAK® CR TIBIAL SLOPE + INSERT | 204 |
| 200-71-XX | OPTETRAK® CR TIBIAL SLOPE ++ INSERT | 148 |
| 200-72-XX | OPTETRAK® CR TIBIAL SLOPE ++ INSERT | 906 |
| 200-73-XX | OPTETRAK® CR TIBIAL SLOPE ++ INSERT | 1030 |
| 200-74-XX | OPTETRAK® CR TIBIAL SLOPE ++ INSERT | 563 |
| 200-75-XX | OPTETRAK® CR TIBIAL SLOPE ++ INSERT | 218 |
| 204-21-XX | OPTETRAK® PS TIBIAL INSERTS | 10048 |
| 204-22-XX | OPTETRAK® PS TIBIAL INSERTS | 38886 |
| 204-23-XX | OPTETRAK® PS TIBIAL INSERTS | 32689 |
| 204-24-XX | OPTETRAK® PS TIBIAL INSERTS | 14623 |
| 204-25-XX | OPTETRAK® PS TIBIAL INSERTS | 4748 |
| 204-26-XX | OPTETRAK® PS TIBIAL INSERTS | 611 |
| 204-50-XX | OPTETRAK® PS TIBIAL INSERTS | 392 |
| 204-51-XX | OPTETRAK® PS TIBIAL INSERTS | 5516 |
| 204-91-XX | OPTETRAK "MOMB" NON-MOD MOLDED INSERT | 282 |
| 204-92-XX | OPTETRAK "MOMB" NON-MOD MOLDED INSERT | 864 |
| 204-93-XX | OPTETRAK "MOMB" NON-MOD MOLDED INSERT | 1167 |
| 204-94-XX | OPTETRAK "MOMB" NON-MOD MOLDED INSERT | 668 |
| 204-95-XX | OPTETRAK "MOMB" NON-MOD MOLDED INSERT | 176 |
| 208-21-XX | OPTETRAK® CC TIBIAL INSERT | 2996 |
| 208-22-XX | OPTETRAK® CC TIBIAL INSERT | 10026 |
| 208-23-XX | OPTETRAK® CC TIBIAL INSERT | 9143 |
| 208-24-XX | OPTETRAK® CC TIBIAL INSERT | 5175 |
| 208-25-XX | OPTETRAK® CC TIBIAL INSERT | 1824 |
| 208-51-XX | OPTETRAK® CC TIBIAL INSERT | 1136 |
| 224-21-XX | OPTETRAK® B-SERIES PS TIBIAL INSERT | 547 |
| 224-22-XX | OPTETRAK® B-SERIES PS TIBIAL INSERT | 1719 |
| 224-23-XX | OPTETRAK® B-SERIES PS TIBIAL INSERT | 1347 |
| 224-24-XX | OPTETRAK® B-SERIES PS TIBIAL INSERT | 453 |
| OPTETRAK® HI-FLEX® Polyethylene Tibial Inserts (TKR) | 51913 | |
| 244-20-XX | OPTETRAK® HI-FLEX® PS Polyethylene Tibial Inserts | 226 |
| 244-21-XX | OPTETRAK® HI-FLEX® PS Polyethylene Tibial Inserts | 6787 |
| 244-22-XX | OPTETRAK® HI-FLEX® PS Polyethylene Tibial Inserts | 18921 |
| 244-23-XX | OPTETRAK® HI-FLEX® PS Polyethylene Tibial Inserts | 15578 |
| 244-24-XX | OPTETRAK® HI-FLEX® PS Polyethylene Tibial Inserts | 7662 |
| 244-25-XX | OPTETRAK® HI-FLEX® PS Polyethylene Tibial Inserts | 2739 |
| ARTHROFOCUS® Polyethylene Tibial Inserts (TKR) | 12 | |
| 256-12-XX | ARTHROFOCUS® Polyethylene Tibial Inserts | 6 |
| 256-13-XX | ARTHROFOCUS® Polyethylene Tibial Inserts | 6 |
| OPTETRAK® Custom Polyethylene Tibial Inserts (TKR) | 41 | |
| 900-06-XX | CUSTOM OPTETRAK® ANGLED PS INSERT | 6 |
| 900-08-XX | CUSTOM OPTETRAK® ANGLED PS INSERT | 6 |
| 900-23-XX | CUSTOM OPTETRAK® CC TIBIAL INSERT | 21 |
| 900-30-XX | CUSTOM OPTETRAK® CC TIBIAL INSERT | 4 |
| 900-33-XX | CUSTOM OPTETRAK® CC INSERT | 4 |
| OPTETRAK® LOGIC® Polyethylene Tibial Inserts (TKR) | 127998 | |
| 02-012-35-XXXX | OPTETRAK® Logic PS Tibial Inserts | 80506 |
| 02-012-44-XXXX | OPTETRAK® Logic PSC Tibial Inserts | 19323 |
| 02-012-47-XXXX | OPTETRAK® Logic CR Tibial Inserts | 9139 |
| 02-012-48-XXXX | OPTETRAK® Logic CR Slope + Tibial Inserts | 3083 |
| 02-012-49-XXXX | OPTETRAK® Logic CR Slope ++ Tibial Inserts | 2853 |
| 02-012-51-XXXX | OPTETRAK® Logic CRC Tibial Inserts | 10291 |
| 02-012-65-XXXX | OPTETRAK® Logic CC Tibial Inserts | 2803 |
| OPTETRAK® RBK® Polyethylene Tibial Inserts (TKR) | 33393 | |
| 264-21-XX | OPTETRAK® RBK PS Tibial Components | 2938 |
| 264-22-XX | OPTETRAK® RBK PS Tibial Components | 10994 |
| 264-23-XX | OPTETRAK® RBK PS Tibial Components | 11560 |
| 264-24-XX | OPTETRAK® RBK PS Tibial Components | 5738 |
| 264-25-XX | OPTETRAK® RBK PS Tibial Components | 2163 |
| TRULIANT® Tibial Inserts (TKR) | 38075 | |
| 02-022-35-XXXX | TRULIANT® PS Tibial Inserts | 20913 |
| 02-022-44-XXXX | TRULIANT® PSC Tibial Inserts | 6519 |
| 02-022-47-XXXX | TRULIANT® CR Tibial Inserts | 3095 |
| 02-022-48-XXXX | TRULIANT® CR Slope + Tibial Inserts | 504 |
| 02-022-49-XXXX | TRULIANT® CR Slope ++ Tibial Inserts | 335 |
| 02-022-51-XXXX | TRULIANT® CRC Tibial Inserts | 6709 |
| OPTETRAK® Logic RBK Tibial Components (TKR) | 10616 | |
| 02-012-38-XXXX | OPTETRAK® Logic RBK PS Tibial Components | 10616 |
| Vantage® Fixed-Bearing Polyethylene Liner Component (TAR) | 2959 | |
| 350-21-XX | Vantage® Fixed-Bearing Polyethylene Liner Component | 1422 |
| 350-22-XX | Vantage® Fixed-Bearing Polyethylene Liner Component | 1537 |
| Vantage® Mobile-Bearing Polyethylene Liner Component (TAR) | 761 | |
| 350-41-XX | Vantage® Mobile-Bearing Polyethylene Liner Component | 352 |
| 350-42-XX | Vantage® Mobile-Bearing Polyethylene Liner Component | 409 |
Exactech Polyethylene Patients: What to do
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 01908 991163 or send an email to exactech.recall@crawco.uk 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:
| Language | Phone | |
|---|---|---|
| French | +32 80026327 | exactech.recall@crawco.be |
| German | +49 (211) 54012549 | exactech.recall@crawco.de |
| Italian | +39 0200704115 | exactech.recall@crawco.it |
| Spanish | +34 900999585 | exactech.recall@crawford-spain.com |
| English | +01908 991163 | exactech.recall@crawco.uk |
