This is an informational page for patients to learn facts about a specific recall and find out if an implant that was packaged in nonconforming packaging was used during your procedure. Click the links below to see if your implant is affected by a recall.
If you have additional questions, please contact our patient resource, Kroll, at https://restructuring.ra.kroll.com/Exactech – or 833.918.0986 (US/Canada Toll-Free) or +1.646.781.8728 (International).
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 |
