Optetrak Logic
Optetrak Logic includes tibial inserts used with the system's tibial trays and femoral knee components. The CRC insert is a modified cruciate-retaining design intended to add constraint…
Optetrak Logic includes tibial inserts used with the system’s tibial trays and femoral knee components. The CRC insert is a modified cruciate-retaining design intended to add constraint when the posterior cruciate ligament is not fully functional.
These inserts are made from ultra-high-molecular-weight polyethylene. Their articulating geometry provides the additional constraint while retaining compatibility with the corresponding Logic knee components.
Listed Item
Head, Tibial Tamp, Tibial Tray, Logic FIT™, Adjustable, NET Shape
Role in Knee Replacement
The insert forms the bearing surface within the knee replacement assembly, between the femoral component and tibial tray. The CRC design is part of the cemented Optetrak Logic knee system and is selected with the associated components for the planned reconstruction.
21manufacturers in China registered for this device type
879catalogue numbers in this listing
32510(k) clearances naming this product code
40recalls on this code
Who Else Makes It
Concentrated in Jiangsu (10), Shanghai (4), Beijing (3). 13 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| b-ONE Medical (Beijing) Co., Ltd. | Beijing | Beijing | Contract manufacturer | 7 |
| Changzhou Wastonortho Medical Appliance Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 5 |
Showing 12 of 21. All 21 manufacturers in China registered for Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Record
| Listed by | Exactech, Inc., United States |
|---|---|
| FDA product code | JWH |
| Device type | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3560 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K123342 |
| Record published | 2015-10-30 |
| Record revised | 2025-08-29 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, serial number |
| Sizes | Height 5 to 52 mm; outer diameter 10 to 24 mm; length 2 to 200 mm; width 29 to 65 mm; lumen/inner diameter 10 to 18 mm |
| Distribution end date | 2024-06-13 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 02-012-51-3515 | Height 15 mm | In distribution |
| 02-010-02-0310 | Size 1 | In distribution |
| 02-012-61-6202 | Outer Diameter 20 mm | In distribution |
| 02-012-41-5050 | Size 5F/5T | In distribution |
| 02-012-47-2013 | Size 2 | In distribution |
| 02-012-44-1513 | Height 13 mm | In distribution |
| 02-012-35-6011 | Size 6 | In distribution |
| 02-010-06-0542 | Size 4 | In distribution |
| 02-012-48-2513 | Height 13 mm | In distribution |
| 02-012-47-3517 | Height 17 mm | In distribution |
| 02-012-65-4021 | Height 21 mm | In distribution |
| 02-012-51-1009 | Size 1 | In distribution |
| 02-012-51-6017 | Size 6 | In distribution |
| 02-012-41-5040 | Size 5F/4T | In distribution |
| 02-012-44-3411 | Height 11 mm | In distribution |
| 02-012-47-1509 | Height 9 mm | In distribution |
| 02-012-35-6013 | Height 13 mm | In distribution |
| 02-012-60-1220 | Outer Diameter 12 mm | In distribution |
| 02-012-61-8246 | 8mm offset | In distribution |
| 02-010-01-0340 | Size 4 | In distribution |
| 02-012-44-2117 | 2F/1T | In distribution |
| 02-012-50-4501 | Height 5 mm | In distribution |
| 02-012-35-3513 | Height 13 mm | In distribution |
| 02-012-49-3013 | Height 13 mm | In distribution |
| 02-012-50-4513 | Right Medial/Left Lateral | In distribution |
| 02-012-44-3515 | Size 3.5 | In distribution |
| 02-012-35-2109 | 2F/1T | In distribution |
| 02-012-35-3111 | Height 11 mm | In distribution |
| 02-019-10-0050 | SIZE 5 | In distribution |
| 02-012-39-6060 | Size 6F/6T | In distribution |
| 02-012-44-2011 | Size 2 | In distribution |
| 02-012-66-6000 | Width 65 mm | In distribution |
| 02-012-50-1513 | Right Medial/Left Lateral | In distribution |
| 02-012-61-6226 | 6mm offset | In distribution |
| 02-012-44-2611 | 2.5F/1.5T | In distribution |
| 02-012-49-3509 | slope + | In distribution |
| 02-012-50-2513 | Right Medial/Left Lateral | In distribution |
| 02-012-65-9117 | Size 1F/1.5T | In distribution |
| 02-010-06-0250 | Left | In distribution |
| 02-012-35-2611 | Height 11 mm | In distribution |
| 02-012-41-3040 | Size 3F/4T | In distribution |
| 02-012-47-5013 | Height 13 mm | In distribution |
| 02-012-41-1020 | Size 1F/2T | In distribution |
| 02-012-48-6011 | Size 6 | In distribution |
| 02-012-44-2109 | 2F/1T | In distribution |
| 02-012-47-1015 | Height 15 mm | In distribution |
| 02-012-39-3525 | Size 3.5F/2.5T | In distribution |
| 02-012-65-9211 | Height 11 mm | In distribution |
| 02-010-66-1002 | Femoral size: Small | In distribution |
| 02-010-02-0260 | Size 6 | In distribution |
| 02-019-10-0120 | SIZE 2 | In distribution |
| 02-010-04-0330 | Size 3 | In distribution |
| 02-012-49-0009 | slope + | In distribution |
| 02-012-50-6014 | Height 10 mm | In distribution |
| 02-012-35-3115 | Height 15 mm | In distribution |
| 02-012-51-0013 | Size 0 | In distribution |
| 02-012-60-1420 | Outer Diameter 14 mm | In distribution |
| 02-012-35-2509 | Height 9 mm | In distribution |
| 02-012-45-5040 | Size 5F/4T | In distribution |
| 02-010-03-0350 | Right | In distribution |
| 02-012-35-1511 | Size 1.5 | In distribution |
| 02-012-44-2019 | Size 2 | In distribution |
| 02-012-65-9313 | Size 3F/3.5T | In distribution |
| 02-012-50-3014 | Size 3 | In distribution |
| 02-012-50-2504 | Height 10 mm | In distribution |
| 02-010-06-0320 | Right | In distribution |
| 02-012-45-4050 | Size 4F/5T | In distribution |
| 02-010-07-5510 | 15mm Distal thickness | In distribution |
| 02-012-48-3509 | Height 9 mm | In distribution |
| 02-012-60-1080 | Length 80 mm | In distribution |
| 02-012-61-8106 | 8mm offset | In distribution |
| 02-012-45-2515 | Size 2.5F/1.5T | In distribution |
| 02-012-44-5011 | Size 5 | In distribution |
| 02-012-48-2509 | Height 9 mm | In distribution |
| 02-012-61-6166 | 6mm offset | In distribution |
| 02-012-44-3115 | Height 15 mm | In distribution |
| 02-012-39-1020 | Size 1F/2T | In distribution |
| 02-010-04-0220 | Size 2 | In distribution |
| 02-012-65-3019 | Height 19 mm | In distribution |
| 02-010-02-0315 | Right | In distribution |
| 02-010-02-0220 | Size 2 | In distribution |
| 02-010-04-0230 | Size 3 | In distribution |
| 02-012-50-6013 | Right Medial/Left Lateral | In distribution |
| 02-012-39-0000 | Size 0F/0T | In distribution |
| 02-012-44-2017 | Height 17 mm | In distribution |
| 02-012-44-3013 | Height 13 mm | In distribution |
| 02-012-47-1517 | Height 17 mm | In distribution |
| 02-019-10-0060 | SIZE 6 | In distribution |
| 02-010-01-0315 | Right | In distribution |
| 02-010-01-0330 | Size 3 | In distribution |
| 213-66-03 | In distribution | |
| 02-010-66-4002 | Height 42 mm | In distribution |
| 02-012-47-3009 | Size 3 | In distribution |
| 02-010-66-3001 | Height 32 mm | In distribution |
| 02-012-47-1513 | Height 13 mm | In distribution |
| 02-010-01-0350 | Right | In distribution |
| 02-010-03-0240 | Size 4 | In distribution |
| 02-012-39-3040 | Size 3F/4T | In distribution |
| 02-012-65-2025 | Height 25 mm | In distribution |
| 02-012-61-6102 | Outer Diameter 10 mm | In distribution |
| 02-012-47-5011 | Size 5 | In distribution |
| 02-012-65-5029 | Height 29 mm | In distribution |
| 02-012-65-9115 | Height 15 mm | In distribution |
| 02-012-44-3015 | Size 3 | In distribution |
| 02-012-49-3009 | Height 9 mm | In distribution |
| 02-012-51-3519 | Height 19 mm | In distribution |
| 02-012-35-1017 | Height 17 mm | In distribution |
| 02-012-51-3011 | Height 11 mm | In distribution |
| 02-012-44-0015 | Size 0 | In distribution |
| 02-012-35-2017 | Height 17 mm | In distribution |
| 02-012-44-6009 | Height 9 mm | In distribution |
| 02-012-61-2126 | 2mm offset | In distribution |
| 02-012-44-2115 | 2F/1T | In distribution |
| 02-012-65-3021 | Size 3 | In distribution |
| 02-012-51-3009 | Size 3 | In distribution |
| 02-010-01-0215 | Left | In distribution |
| 02-010-01-0220 | Size 2 | In distribution |
| 02-012-48-4013 | Size 4 | In distribution |
| 02-012-39-3020 | Size 3F/2T | In distribution |
| 02-012-65-1015 | Size 1 | In distribution |
| 02-012-51-0019 | Height 19 mm | In distribution |
| 02-012-50-0501 | 1/3 | In distribution |
| 213-75-00 | In distribution | |
| 02-012-65-9319 | Height 19 mm | In distribution |
| 02-012-60-1816 | Length 160 mm | In distribution |
| 02-010-06-0210 | Left | In distribution |
| 02-012-35-3011 | Size 3 | In distribution |
| 02-012-50-2001 | 1/3 | In distribution |
| 02-012-65-9317 | Size 3F/3.5T | In distribution |
| 02-012-44-2609 | Height 9 mm | In distribution |
| 02-012-35-5011 | Size 5 | In distribution |
| 02-010-03-0215 | Left | In distribution |
| 02-010-06-0522 | Size 2 | In distribution |
| 02-010-06-0330 | Size 3 | In distribution |
| 02-010-01-0225 | Left | In distribution |
| 02-012-35-2111 | Height 11 mm | In distribution |
| 02-019-11-0040 | SIZE 4 | In distribution |
| 02-012-50-4014 | Size 4 | In distribution |
| 02-012-49-5009 | slope + | In distribution |
| 02-012-47-1009 | Size 1 | In distribution |
| 02-012-51-1013 | Size 1 | In distribution |
| 02-012-51-2009 | Size 2 | In distribution |
| 02-012-48-1009 | Size 1 | In distribution |
| 02-012-65-9315 | Height 15 mm | In distribution |
| 02-012-41-6060 | Size 6F/6T | In distribution |
| 02-010-03-0335 | Right | In distribution |
| 02-012-44-3019 | Size 3 | In distribution |
| 02-012-51-2517 | Size 2.5 | In distribution |
| 02-012-51-3013 | Size 3 | In distribution |
| 02-012-50-5014 | Height 10 mm | In distribution |
| 02-012-44-4017 | Height 17 mm | In distribution |
| 02-012-65-9125 | Size 1F/1.5T | In distribution |
| 02-012-61-6106 | 6mm offset | In distribution |
| 02-012-49-5011 | Height 11 mm | In distribution |
| 02-012-49-6009 | Height 9 mm | In distribution |
| 02-010-07-1510 | 10mm Posterior thickness | In distribution |
| 02-012-47-6011 | Height 11 mm | In distribution |
| 02-010-04-0325 | Right | In distribution |
| 02-012-61-2182 | Outer Diameter 18 mm | In distribution |
| 02-010-02-0325 | Right | In distribution |
| 02-010-04-0320 | Size 2 | In distribution |
| 02-012-44-5015 | Size 5 | In distribution |
| 02-012-65-4015 | Height 15 mm | In distribution |
| 02-012-50-5013 | Right Medial/Left Lateral | In distribution |
| 02-012-47-3011 | Height 11 mm | In distribution |
| 02-012-35-2615 | Height 15 mm | In distribution |
| 02-012-50-5011 | Height 5 mm | In distribution |
| 02-012-60-1680 | Length 80 mm | In distribution |
| 02-012-35-2515 | Size 2.5 | In distribution |
| 02-012-50-2014 | Size 2 | In distribution |
| 02-012-51-4019 | Height 19 mm | In distribution |
| 02-012-35-2019 | Size 2 | In distribution |
| 02-012-44-2009 | Height 9 mm | In distribution |
| 02-012-60-2416 | Length 160 mm | In distribution |
| 02-010-02-0240 | Size 4 | In distribution |
| 02-012-35-3019 | Size 3 | In distribution |
| 02-012-41-3535 | Size 3.5F/3.5T | In distribution |
| 02-010-03-0235 | Left | In distribution |
| 02-010-07-1015 | 15mm Posterior thickness | In distribution |
| 02-012-39-3535 | Size 3.5F/3.5T | In distribution |
| 02-012-44-3513 | Height 13 mm | In distribution |
| 02-012-60-2412 | Outer Diameter 24 mm | In distribution |
| 02-012-51-5017 | Size 5 | In distribution |
| 02-010-03-0260 | Size 6 | In distribution |
| 02-010-02-0225 | Left | In distribution |
| 02-012-48-2011 | Height 11 mm | In distribution |
| 02-012-50-3504 | Height 10 mm | In distribution |
| 02-012-51-4013 | Size 4 | In distribution |
| 02-012-60-2080 | Length 80 mm | In distribution |
| 02-012-35-1009 | Height 9 mm | In distribution |
| 02-012-65-9113 | Size 1F/1.5T | In distribution |
| 02-012-50-3513 | Right Medial/Left Lateral | In distribution |
| 02-012-44-2509 | Height 9 mm | In distribution |
| 02-012-60-1620 | Outer Diameter 16 mm | In distribution |
| 02-012-61-8182 | Outer Diameter 18 mm | In distribution |
| 02-012-65-5017 | Size 5 | In distribution |
| 02-012-45-1515 | Size 1.5F/1.5T | In distribution |
| 02-012-51-4015 | Height 15 mm | In distribution |
| 02-010-07-3510 | 15mm Distal thickness | In distribution |
| 02-012-44-0011 | Size 0 | In distribution |
| 02-012-61-2162 | Outer Diameter 16 mm | In distribution |
| 02-012-39-4050 | Size 4F/5T | In distribution |
| 02-012-65-9325 | Size 3F/3.5T | In distribution |
| 02-012-51-1011 | Height 11 mm | In distribution |
| 02-012-44-3509 | Height 9 mm | In distribution |
| 02-012-39-2030 | Size 2F/3T | In distribution |
| 02-012-51-2519 | Height 19 mm | In distribution |
| 02-012-65-9215 | Height 15 mm | In distribution |
| 02-012-65-1013 | Height 13 mm | In distribution |
| 02-012-41-1505 | Size 1.5F/0.5T | In distribution |
| 02-012-60-1020 | Outer Diameter 10 mm | In distribution |
| 02-010-66-2003 | Femoral size: Medium | In distribution |
| 02-010-01-0250 | Left | In distribution |
| 02-012-50-1014 | Height 10 mm | In distribution |
| 02-012-50-2013 | Height 10 mm | In distribution |
| 02-012-50-2501 | Height 5 mm | In distribution |
| 02-010-03-0250 | Left | In distribution |
| 02-012-39-2535 | Size 2.5F/3.5T | In distribution |
| 02-012-47-4011 | Height 11 mm | In distribution |
| 02-012-49-4013 | Height 13 mm | In distribution |
| 02-012-41-4030 | Size 4F/3T | In distribution |
| 02-012-51-3509 | Size 3.5 | In distribution |
| 02-012-35-2113 | 2F/1T | In distribution |
| 02-012-41-2515 | Size 2.5F/1.5T | In distribution |
| 02-012-35-3517 | Height 17 mm | In distribution |
| 02-010-04-0340 | Size 4 | In distribution |
| 02-012-35-0017 | Height 17 mm | In distribution |
| 02-012-35-2513 | Height 13 mm | In distribution |
| 02-010-02-0330 | Size 3 | In distribution |
| 02-012-35-5017 | Height 17 mm | In distribution |
| 02-012-35-2613 | 2.5F/1.5T | In distribution |
| 02-012-41-2030 | Size 2F/3T | In distribution |
| 02-012-49-1509 | slope + | In distribution |
| 02-010-04-0300 | Right | In distribution |
| 02-012-44-1515 | Size 1.5 | In distribution |
| 02-012-51-2011 | Height 11 mm | In distribution |
| 02-012-50-3011 | Size 3 | In distribution |
| 02-012-35-0019 | Size 0 | In distribution |
| 02-012-65-4011 | Height 11 mm | In distribution |
| 02-012-45-1525 | Size 1.5F/2.5T | In distribution |
| 02-010-66-3003 | Height 52 mm | In distribution |
| 02-012-41-2020 | Size 2F/2T | In distribution |
| 02-012-49-5013 | slope + | In distribution |
| 02-012-44-0019 | Size 0 | In distribution |
| 02-012-41-0010 | Size 0F/1T | In distribution |
| 213-75-01 | In distribution | |
| 02-012-65-5021 | Height 21 mm | In distribution |
| 02-012-51-2515 | Height 15 mm | In distribution |
| 02-012-44-3119 | Height 19 mm | In distribution |
| 02-010-02-0210 | Size 1 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Prophecy® | Microport Orthopedics Inc. | 4,423 |
| Exult Knee Replacement System | Corentec Co., Ltd. | 1,770 |
| Freedom | Maxx Orthopedics Inc. | 1,693 |
| Legion | Smith & Nephew, Inc. | 1,534 |
| MyKnee | Medacta International SA | 1,466 |
| Journey | Smith & Nephew, Inc. | 1,339 |
| Persona® | Zimmer, Inc. | 1,254 |
| DJO Surgical | Encore Medical, L.P. | 1,131 |
| U2 Total Knee System | United Orthopedic Corp. | 1,078 |
| CKS Plus | Shalby Advanced Technologies, Inc. | 1,024 |
| Lospa Modular Knee System | Corentec Co., Ltd. | 1,020 |
| Natural-Knee® | Zimmer, Inc. | 980 |
Showing 12 of 1,175. All products under Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K223252 | 2023-07-17 |
| K171045 | 2017-04-28 |
| K170240 | 2017-02-23 |
| K153595 | 2016-03-25 |
| K160484 | 2016-03-18 |
| K152170 | 2015-09-03 |
| K150890 | 2015-05-29 |
| K132161 | 2013-10-11 |
| K123687 | 2013-03-20 |
| K123342 | 2013-01-10 |
| K121307 | 2012-05-31 |
| K111400 | 2011-07-28 |
| K101981 | 2010-08-02 |
| K093360 | 2010-01-11 |
| K082022 | 2008-09-02 |
| K071738 | 2007-08-15 |
| K032522 | 2004-05-28 |
| K033883 | 2004-02-13 |
| K032606 | 2003-09-23 |
| K030686 | 2003-04-02 |
| K023186 | 2002-10-17 |
| K012251 | 2001-07-31 |
| K011976 | 2001-07-16 |
| K010434 | 2001-03-13 |
| K954208 | 1996-02-26 |
| K933494 | 1995-03-10 |
| K932690 | 1995-02-09 |
| K933610 | 1995-01-17 |
| K935773 | 1994-12-09 |
| K932776 | 1994-10-20 |
| K935726 | 1994-10-20 |
| K936079 | 1994-09-07 |
Recalls Naming This Product
19 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Exactech, Inc. | 510(k) number | 2024-04-18 | Class II | Under Investigation by firm | Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags. | ||
| Exactech, Inc. | 510(k) number | 2024-04-18 | Class II | Under Investigation by firm | Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags. | ||
| Exactech, Inc. | 510(k) number | 2024-04-18 | Class II | Under Investigation by firm | Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags. | ||
| Exactech, Inc. | 510(k) number | 2024-04-18 | Class II | Under Investigation by firm | Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags. | ||
| Exactech, Inc. | 510(k) number | 2023-11-21 | Class II | Packaging change control | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. | ||
| Exactech, Inc. | 510(k) number | 2023-11-21 | Class II | Packaging change control | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. | ||
| Exactech, Inc. | 510(k) number | 2023-11-21 | Class II | Packaging change control | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. | ||
| Exactech, Inc. | 510(k) number | 2021-08-30 | Class II | Process control | Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. | 109,787 devices | |
| Exactech, Inc. | 510(k) number | 2020-01-27 | Class II | Labeling mix-ups | These Truliant Splined Stem Extension, 18mm x 120mm were found to have a labeling error. The upper right corner of the label incorrectly identifies the implant size as 17mm x 80mm when the implant size is 18mm x 120mm. | 4 units | |
| Exactech, Inc. | 510(k) number | 2018-05-08 | Class II | Under Investigation by firm | Potentially have non-conforming internal threads. | 1 | |
| Exactech, Inc. | 510(k) number | 2017-04-07 | Class II | Process control | Missing Screw in carton. Nine (9) serial numbers were identified as being inadvertently packaged as one per carton when two per carton are required. | 9 devices | 2020-08-04 |
| Exactech, Inc. | 510(k) number | 2014-10-09 | Class II | Labeling mix-ups | Mislabeled | 96 | 2016-06-08 |
| Exactech, Inc. | 510(k) number | 2013-02-01 | Class II | Device Design | A dimensional mismatch was identified which can potentially allow for interference between devices. | 123 devices | 2014-09-22 |
| Exactech, Inc. | 510(k) number | 2011-10-17 | Class II | Device Design | Exactech, Inc. of Gainesville, FL recalled their Optetrak Proximal Tibial Spacer after the devices were determined to be dimensionally incompatible to mate as intended with the Logic Tibial Tray. | 70 | 2013-11-07 |
| Exactech, Inc. | 510(k) number | 2011-09-23 | Class II | Labeling mix-ups | Exactech, Inc. Gainesville, FL is recalling their Optetrak Cemented Trapezoid Tibial Tray, Size 1F/1T, 2F/1T and the Optetrak Rotating Bearing Knee Tibial Tray, Finned, Cemented Tibial Tray, Size 2F/1T. Both trays have the potential to be | 16 | 2014-06-11 |
| Exactech, Inc. | 510(k) number | 2011-08-19 | Class II | Device Design | Exactech, Inc. of Gainesville, FL is recalling their Optetrak Logic Posterior Stabilized Tibial Insert, Size 6 after the device was determined to be out of dimensional specification. | 193 | 2013-11-07 |
| Exactech, Inc. | 510(k) number | 2005-12-19 | Not classified | Other | An implant within a lot of finned tibial trays manufactured at Exactech was not made to specification. The locking cavity in the tibial tray was not fully machined thus preventing the tibial insert from locking in place. | 14 implants from manufactured lot | 2012-06-29 |
| Exactech, Inc. | 510(k) number | 2005-06-02 | Not classified | Other | Implant was identified incorrectly at the time of manufacture and then laser etched with the incorrect size information. | 41 | 2008-10-24 |
| Exactech, Inc. | 510(k) number | 2004-11-11 | Not classified | Other | Implant was identified incorrectly at the time of manufacture and was then labeled and distributed with the incorrect size information. | 21 implants | 2012-05-03 |
Recalls
30 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2023-11-21 | Class II | Packaging change control | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. | ||
| 2023-11-21 | Class II | Packaging change control | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. | ||
| 2021-08-30 | Class II | Process control | Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. | 33,103 devices | |
| 2021-08-30 | Class II | Process control | Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. | 242,397 devices | |
| 2021-08-30 | Class II | Process control | Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. | 12 devices | |
| 2021-08-30 | Class II | Process control | Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. | 31,201 devices | |
| 2021-08-30 | Class II | Process control | Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. | 8,985 devices | |
| 2021-08-30 | Class II | Process control | Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. | 41 devices | |
| 2019-03-13 | Class II | Under Investigation by firm | 2.5 Truliant Fit Trays were mismarked as 3 | 18 units | 2021-04-22 |
| 2017-09-19 | Class II | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. | 665 devices | 2021-06-21 |
| 2017-09-19 | Class II | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. | 801 devices | 2021-06-21 |
| 2017-09-19 | Class II | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. | 198 devices | 2021-06-21 |
| 2017-09-19 | Class II | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. | 678 devices | 2021-06-21 |
| 2017-09-19 | Class II | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. | 411 devices | 2021-06-21 |
| 2017-09-19 | Class II | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. | 889 devices | 2021-06-21 |
| 2017-09-19 | Class II | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. | 606 devices | 2021-06-21 |
| 2017-09-19 | Class II | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. | 311 devices | 2021-06-21 |
| 2017-09-19 | Class II | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. | 386 devices | 2021-06-21 |
| 2017-09-19 | Class II | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. | 333 devices | 2021-06-21 |
| 2017-09-19 | Class II | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. | 733 devices | 2021-06-21 |
| 2017-09-19 | Class II | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. | 207 devices | 2021-06-21 |
| 2017-09-19 | Class II | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. | 527 devices | 2021-06-21 |
| 2017-09-19 | Class II | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. | 575 devices | 2021-06-21 |
| 2017-09-19 | Class II | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. | 643 devices | 2021-06-21 |
| 2017-09-19 | Class II | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. | 109 devices | 2021-06-21 |
| 2017-09-19 | Class II | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. | 547 devices | 2021-06-21 |
| 2017-09-19 | Class II | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. | 656 devices | 2021-06-21 |
| 2017-09-19 | Class II | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. | 953 devices | 2021-06-21 |
| 2017-09-19 | Class II | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. | 893 devices | 2021-06-21 |
| 2017-09-19 | Class II | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. | 114 devices | 2021-06-21 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.