Duracon
Cemented Constrained PS Tibial Insert
21manufacturers in China registered for this device type
338catalogue 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 | Howmedica Osteonics Corp, 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 | Contract manufacturer, Contract steriliser, Specification developer, Manufacturer |
| 510(k) | K223069 |
| Record published | 2015-09-24 |
| Record revised | 2024-05-22 (version 6) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
| Sizes | Length 80 to 155 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6478-6-437 | Length 155.0 mm | In distribution |
| 6630-6-515 | Thickness: 10.0 Millimeter | In distribution |
| 6632-3-640 | Anterior/Posterior Width: 60.0 Millimeter | In distribution |
| 6478-6-430 | Alpha Code: X | In distribution |
| 6637-0-331 | Size: XLGE | In distribution |
| 6642-2-100 | Size: MED | In distribution |
| 6478-6-665 | Length 80.0 mm | In distribution |
| 6478-6-399 | Length 80.0 mm | In distribution |
| 6742-1-225 | Size: MED | In distribution |
| 6642-5-125 | Thickness: 25.0 Millimeter | In distribution |
| 6642-1-825 | Size: LGE | In distribution |
| 6478-6-615 | Diameter: 13.0 Millimeter | In distribution |
| 6630-6-210 | Thickness: 10.0 Millimeter | In distribution |
| 6642-5-128 | Size: SM | In distribution |
| 6642-9-809 | Size: LGE | In distribution |
| 6637-0-611 | Size: SM | In distribution |
| 6637-4-025 | Size: SM | In distribution |
| 6637-0-709 | Size: MED | In distribution |
| 6637-0-131 | Thickness: 31.0 Millimeter | In distribution |
| 6752-5-422 | Thickness: 22.0 Millimeter | In distribution |
| 6637-4-328 | Thickness: 28.0 Millimeter | In distribution |
| 6637-0-313 | Side: LEFT | In distribution |
| 6642-2-631 | Diameter: 31.0 Millimeter | In distribution |
| 6630-6-105 | Size: SM-1 | In distribution |
| 6742-1-419 | Thickness: 19.0 Millimeter | In distribution |
| 6478-6-460 | Alpha Code: Q | In distribution |
| 6630-6-330 | Size: LGE-1 | In distribution |
| 6642-5-122 | Size: SM | In distribution |
| 6478-6-725 | Length 155.0 mm | In distribution |
| 6742-1-109 | Thickness: 9.0 Millimeter | In distribution |
| 6630-6-470 | Size: XLGE-2 | In distribution |
| 6630-6-510 | Size: SM-1 | In distribution |
| 6742-4-216 | Thickness: 16.0 Millimeter | In distribution |
| 6630-6-275 | Size: MED-2 | In distribution |
| 6642-2-610 | Thickness: 8.0 Millimeter | In distribution |
| 6637-0-625 | Side: RIGHT | In distribution |
| 6642-1-609 | Size: SM | In distribution |
| 6637-0-222 | Size: LGE | In distribution |
| 6478-6-450 | Length 155.0 mm | In distribution |
| 6637-0-716 | Side: RIGHT | In distribution |
| 6630-6-520 | Size: MED-1 | In distribution |
| 6642-1-513 | Size: XSM | In distribution |
| 6637-0-622 | Side: RIGHT | In distribution |
| 6630-6-350 | Size: LGE-2 | In distribution |
| 6478-6-695 | Alpha Code: D | In distribution |
| 6642-2-633 | Diameter: 33.0 Millimeter | In distribution |
| 6742-4-009 | Size: XSM | In distribution |
| 6632-0-750 | In distribution | |
| 6752-5-225 | Thickness: 25.0 Millimeter | In distribution |
| 6478-6-750 | Diameter: 23.0 Millimeter | In distribution |
| 6642-5-219 | Size: MED | In distribution |
| 6637-0-028 | Side: LEFT | In distribution |
| 6478-6-630 | Alpha Code: L | In distribution |
| 6637-4-028 | Size: SM | In distribution |
| 6642-5-419 | Thickness: 19.0 Millimeter | In distribution |
| 6637-0-813 | Size: LGE | In distribution |
| 6637-4-331 | Size: XLGE | In distribution |
| 6637-0-128 | Thickness: 28.0 Millimeter | In distribution |
| 6637-0-609 | Side: RIGHT | In distribution |
| 6752-5-119 | Size: SM | In distribution |
| 6642-5-431 | Size: XLGE | In distribution |
| 6637-0-311 | Size: XLGE | In distribution |
| 6478-6-398 | Diameter: 13.0 Millimeter | In distribution |
| 6478-6-465 | Diameter: 21.0 Millimeter | In distribution |
| 6752-5-113 | Thickness: 13.0 Millimeter | In distribution |
| 6630-6-535 | Size: LGE-2 | In distribution |
| 6478-6-705 | Length 155.0 mm | In distribution |
| 6742-1-416 | Size: XLGE | In distribution |
| 6642-5-231 | Thickness: 31.0 Millimeter | In distribution |
| 6637-4-009 | Thickness: 9.0 Millimeter | In distribution |
| 6637-4-319 | Size: XLGE | In distribution |
| 6742-1-325 | Size: LGE | In distribution |
| 6752-5-416 | Thickness: 16.0 Millimeter | In distribution |
| 6752-5-419 | Size: XLGE | In distribution |
| 6630-6-270 | Thickness: 5.0 Millimeter | In distribution |
| 6742-4-413X | Thickness: 13.0 Millimeter | In distribution |
| 6637-0-822 | Side: RIGHT | In distribution |
| 6637-0-228 | Side: LEFT | In distribution |
| 6630-6-130 | Thickness: 10.0 Millimeter | In distribution |
| 6642-5-316 | Size: LGE | In distribution |
| 6642-2-629 | Diameter: 29.0 Millimeter | In distribution |
| 6752-5-228 | Size: MED | In distribution |
| 6630-6-450 | Size: XLGE-2 | In distribution |
| 6637-0-831 | Side: RIGHT | In distribution |
| 6742-4-125 | Size: SM | In distribution |
| 6642-5-411 | Size: XLGE | In distribution |
| 6752-5-313 | Thickness: 13.0 Millimeter | In distribution |
| 6478-6-439 | Diameter: 14.0 Millimeter | In distribution |
| 6642-2-040 | Thickness: 9.0 Millimeter | In distribution |
| 6478-6-470 | Alpha Code: X | In distribution |
| 6637-0-819 | Side: RIGHT | In distribution |
| 6642-2-627 | Thickness: 10.0 Millimeter | In distribution |
| 6630-6-205 | Size: MED-1 | In distribution |
| 6637-4-313 | Size: XLGE | In distribution |
| 6637-0-119 | Size: MED | In distribution |
| 6742-4-119 | Type: CS | In distribution |
| 6637-0-316 | Thickness: 16.0 Millimeter | In distribution |
| 6630-6-230 | Size: MED-1 | In distribution |
| 6752-5-122 | Size: SM | In distribution |
| 6642-5-313 | Thickness: 13.0 Millimeter | In distribution |
| 6642-5-228 | Thickness: 28.0 Millimeter | In distribution |
| 6478-6-445 | Length 155.0 mm | In distribution |
| 6642-5-225 | Size: MED | In distribution |
| 6742-1-116 | Thickness: 16.0 Millimeter | In distribution |
| 6742-1-211 | Thickness: 11.0 Millimeter | In distribution |
| 6742-4-011 | Thickness: 11.0 Millimeter | In distribution |
| 6642-1-725 | Thickness: 25.0 Millimeter | In distribution |
| 6637-0-925 | Size: XLGE | In distribution |
| 6637-4-322 | Size: XLGE | In distribution |
| 6637-4-211 | Size: LGE | In distribution |
| 6478-6-690 | Length 155.0 mm | In distribution |
| 6630-6-530 | Size: LGE-1 | In distribution |
| 6630-6-310 | Thickness: 10.0 Millimeter | In distribution |
| 6742-1-111 | Thickness: 11.0 Millimeter | In distribution |
| 6742-1-219 | Thickness: 19.0 Millimeter | In distribution |
| 6637-4-213 | Thickness: 13.0 Millimeter | In distribution |
| 6742-4-413 | Type: CS | In distribution |
| 6642-5-331 | Thickness: 31.0 Millimeter | In distribution |
| 6478-6-655 | Length 80.0 mm | In distribution |
| 6642-1-911 | Thickness: 11.0 Millimeter | In distribution |
| 6637-0-216 | Side: LEFT | In distribution |
| 6742-1-311 | Thickness: 11.0 Millimeter | In distribution |
| 6752-5-213 | Thickness: 13.0 Millimeter | In distribution |
| 6478-6-397 | Length 80.0 mm | In distribution |
| 6637-4-311 | Thickness: 11.0 Millimeter | In distribution |
| 6478-6-680 | Alpha Code: N | In distribution |
| 6742-1-411 | Thickness: 11.0 Millimeter | In distribution |
| 6642-5-325 | Thickness: 25.0 Millimeter | In distribution |
| 6642-1-919 | Size: XLGE | In distribution |
| 6742-1-119 | Thickness: 19.0 Millimeter | In distribution |
| 6637-0-711 | Size: MED | In distribution |
| 6632-3-625 | Anterior/Posterior Width: 53.0 Millimeter | In distribution |
| 6637-4-031 | Size: SM | In distribution |
| 6742-4-313 | Size: LGE | In distribution |
| 6632-3-615 | Medial/Lateral Width: 72.0 Millimeter | In distribution |
| 6642-5-319 | Thickness: 19.0 Millimeter | In distribution |
| 6637-0-209 | Thickness: 9.0 Millimeter | In distribution |
| 6637-0-013 | Size: SM | In distribution |
| 6478-6-635 | Alpha Code: G | In distribution |
| 6742-1-413 | Thickness: 13.0 Millimeter | In distribution |
| 6752-5-111 | Size: SM | In distribution |
| 6642-2-626 | Diameter: 25.0 Millimeter | In distribution |
| 6752-5-325 | Size: LGE | In distribution |
| 6637-4-119 | Thickness: 19.0 Millimeter | In distribution |
| 6637-4-309 | Size: XLGE | In distribution |
| 6742-1-313 | Size: LGE | In distribution |
| 6637-0-825 | Side: RIGHT | In distribution |
| 6630-6-170 | Size: SM-2 | In distribution |
| 6642-1-616 | Thickness: 16.0 Millimeter | In distribution |
| 6478-6-425 | Diameter: 21.0 Millimeter | In distribution |
| 6637-0-828 | Size: LGE | In distribution |
| 6630-6-425 | Size: XLGE-1 | In distribution |
| 6637-0-713 | Thickness: 13.0 Millimeter | In distribution |
| 6637-0-116 | Size: MED | In distribution |
| 6637-0-922 | Side: RIGHT | In distribution |
| 6632-3-603 | Medial/Lateral Width: 64.0 Millimeter | In distribution |
| 6637-0-631 | Thickness: 31.0 Millimeter | In distribution |
| 6478-6-420 | Diameter: 19.0 Millimeter | In distribution |
| 6630-6-405 | Size: XLGE-1 | In distribution |
| 6630-6-475 | Size: XLGE-2 | In distribution |
| 6630-6-550 | Size: XLGE-2 | In distribution |
| 6478-6-396 | Diameter: 11.0 Millimeter | In distribution |
| 6742-4-209 | Thickness: 9.0 Millimeter | In distribution |
| 6478-6-620 | Diameter: 14.0 Millimeter | In distribution |
| 6742-4-116 | Size: SM | In distribution |
| 6642-5-425 | Size: XLGE | In distribution |
| 6637-4-011 | Thickness: 11.0 Millimeter | In distribution |
| 6632-3-605 | Size: SM-1 | In distribution |
| 6637-0-725 | Thickness: 25.0 Millimeter | In distribution |
| 6637-4-016 | Size: SM | In distribution |
| 6478-6-710 | Alpha Code: R | In distribution |
| 6637-0-913 | Thickness: 13.0 Millimeter | In distribution |
| 6752-5-128 | Size: SM | In distribution |
| 6742-4-225 | Thickness: 25.0 Millimeter | In distribution |
| 6637-0-016 | Size: SM | In distribution |
| 6742-1-322 | Thickness: 22.0 Millimeter | In distribution |
| 6637-4-022 | Thickness: 22.0 Millimeter | In distribution |
| 6642-9-613 | Thickness: 13.0 Millimeter | In distribution |
| 6637-0-616 | Size: SM | In distribution |
| 6642-5-213 | Size: MED | In distribution |
| 6630-6-225 | Thickness: 5.0 Millimeter | In distribution |
| 6630-6-370 | Size: LGE-2 | In distribution |
| 6478-6-438 | Length 155.0 mm | In distribution |
| 6752-5-222 | Thickness: 22.0 Millimeter | In distribution |
| 6642-5-328 | Thickness: 28.0 Millimeter | In distribution |
| 6478-6-395 | Alpha Code: N | In distribution |
| 6478-6-640 | Diameter: 18.0 Millimeter | In distribution |
| 6642-5-422 | Thickness: 22.0 Millimeter | In distribution |
| 6637-0-011 | Thickness: 11.0 Millimeter | In distribution |
| 6642-5-119 | Size: SM | In distribution |
| 6637-0-613 | Thickness: 13.0 Millimeter | In distribution |
| 6637-4-231 | Thickness: 31.0 Millimeter | In distribution |
| 6630-6-355 | Size: LGE-2 | In distribution |
| 6637-4-111 | Thickness: 11.0 Millimeter | In distribution |
| 6637-0-325 | Thickness: 25.0 Millimeter | In distribution |
| 6637-0-022 | Side: LEFT | In distribution |
| 6637-0-019 | Size: SM | In distribution |
| 6637-4-222 | Size: LGE | In distribution |
| 6637-0-031 | Thickness: 31.0 Millimeter | In distribution |
| 6478-6-400 | Alpha Code: R | In distribution |
| 6478-6-720 | Alpha Code: G | In distribution |
| 6752-5-211 | Size: MED | In distribution |
| 6637-0-628 | Size: SM | In distribution |
| 6632-3-620 | Size: MED-2 | In distribution |
| 6478-6-625 | Alpha Code: R | In distribution |
| 6637-4-128 | Thickness: 28.0 Millimeter | In distribution |
| 6637-0-931 | Size: XLGE | In distribution |
| 6742-1-209 | Size: MED | In distribution |
| 6642-5-222 | Size: MED | In distribution |
| 6742-1-216 | Size: MED | In distribution |
| 6630-6-375 | Size: LGE-2 | In distribution |
| 6637-0-025 | Size: SM | In distribution |
| 6637-4-013 | Size: SM | In distribution |
| 6630-6-430 | Thickness: 10.0 Millimeter | In distribution |
| 6632-3-630 | Medial/Lateral Width: 79.0 Millimeter | In distribution |
| 6742-4-113 | Type: CS | In distribution |
| 6637-4-209 | Thickness: 9.0 Millimeter | In distribution |
| 6637-0-319 | Size: XLGE | In distribution |
| 6637-0-322 | Thickness: 22.0 Millimeter | In distribution |
| 6742-1-422 | Size: XLGE | In distribution |
| 6637-0-928 | Size: XLGE | In distribution |
| 6630-6-155 | Size: SM-2 | In distribution |
| 6742-4-311 | Type: CS | In distribution |
| 6742-1-409 | Size: XLGE | In distribution |
| 6637-0-722 | Size: MED | In distribution |
| 6742-1-222 | Size: MED | In distribution |
| 6642-5-111 | Size: SM | In distribution |
| 6637-0-219 | Side: LEFT | In distribution |
| 6630-6-525 | Thickness: 10.0 Millimeter | In distribution |
| 6637-4-225 | Size: LGE | In distribution |
| 6478-6-605 | Diameter: 11.0 Millimeter | In distribution |
| 6642-5-131 | Size: SM | In distribution |
| 6630-6-455 | Thickness: 10.0 Millimeter | In distribution |
| 6630-6-150 | Size: SM-2 | In distribution |
| 6478-6-410 | Diameter: 17.0 Millimeter | In distribution |
| 6752-5-319 | Size: LGE | In distribution |
| 6637-0-728 | Side: RIGHT | In distribution |
| 6742-1-309 | Size: LGE | In distribution |
| 6637-4-216 | Thickness: 16.0 Millimeter | In distribution |
| 6752-5-316 | Thickness: 16.0 Millimeter | In distribution |
| 6478-6-740 | Diameter: 21.0 Millimeter | In distribution |
| 6642-5-413 | Size: XLGE | In distribution |
| 6637-0-816 | Size: LGE | In distribution |
| 6642-5-211 | Thickness: 11.0 Millimeter | In distribution |
| 6637-0-328 | Side: LEFT | In distribution |
| 6637-0-109 | Thickness: 9.0 Millimeter | In distribution |
| 6642-5-311 | Thickness: 11.0 Millimeter | In distribution |
| 6630-6-410 | Thickness: 10.0 Millimeter | In distribution |
| 6637-0-009 | Side: LEFT | In distribution |
| 6642-1-611 | Thickness: 11.0 Millimeter | 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 |
|---|---|
| K123166 | 2013-02-14 |
| K072221 | 2007-10-15 |
| K071991 | 2007-08-15 |
| K070095 | 2007-06-01 |
| K063423 | 2007-01-22 |
| K062037 | 2006-08-03 |
| K051977 | 2005-10-12 |
| K051146 | 2005-07-13 |
| K050539 | 2005-03-29 |
| K042343 | 2005-02-09 |
| K042993 | 2005-01-12 |
| K042883 | 2004-11-23 |
| K041591 | 2004-09-23 |
| K040964 | 2004-05-28 |
| K040267 | 2004-05-05 |
| K033342 | 2004-01-15 |
| K032829 | 2003-12-10 |
| K030978 | 2003-11-20 |
| K032479 | 2003-09-04 |
| K031729 | 2003-09-02 |
| K023724 | 2003-02-03 |
| K020703 | 2002-11-13 |
| K021451 | 2002-10-18 |
| K020830 | 2002-06-06 |
| K012776 | 2001-11-16 |
| K012172 | 2001-10-10 |
| K011643 | 2001-06-28 |
| K001147 | 2001-02-15 |
| K000091 | 2000-03-10 |
| K994128 | 2000-03-06 |
| K993692 | 1999-12-02 |
| K991461 | 1999-05-17 |
Recalls Naming This Product
28 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Howmedica Osteonics Corp | 510(k) number | 2026-07-30 | Not classified | Process change control | Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to | 12,156 US | |
| Howmedica Osteonics Corp | 510(k) number | 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | 107 units US; 176 units OUS | |
| Howmedica Osteonics Corp | 510(k) number | 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | 1 units US; 146 units oUS | |
| Howmedica Osteonics Corp | 510(k) number | 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | 137 units US; 326 units OUS | |
| Howmedica Osteonics Corp | 510(k) number | 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | 149 units US; 424 units OUS | |
| Howmedica Osteonics Corp | 510(k) number | 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | 118 units US; 212 units OUS | |
| Howmedica Osteonics Corp | 510(k) number | 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | 4 units US | |
| Howmedica Osteonics Corp | UDI-DI | 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | ||
| Howmedica Osteonics Corp | 510(k) number | 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | ||
| Howmedica Osteonics Corp | 510(k) number | 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | ||
| Howmedica Osteonics Corp | 510(k) number | 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | ||
| Howmedica Osteonics Corp | 510(k) number | 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | ||
| Howmedica Osteonics Corp | 510(k) number | 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | ||
| Howmedica Osteonics Corp | 510(k) number | 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | ||
| Howmedica Osteonics Corp | 510(k) number | 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | ||
| Howmedica Osteonics Corp | 510(k) number | 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | ||
| Howmedica Osteonics Corp | 510(k) number | 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | ||
| Howmedica Osteonics Corp | 510(k) number | 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | ||
| Howmedica Osteonics Corp | 510(k) number | 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | ||
| Howmedica Osteonics Corp | 510(k) number | 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | ||
| Howmedica Osteonics Corp | 510(k) number | 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | ||
| Howmedica Osteonics Corp | 510(k) number | 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | ||
| Howmedica Osteonics Corp | UDI-DI | 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | ||
| Howmedica Osteonics Corp | 510(k) number | 2015-09-21 | Class II | Under Investigation by firm | Stryker Orthopaedics has received two customer complaints regarding Duracon Tibial Wedge implants puncturing the packaging’s Tyvek lid(s). | 2,577 units | 2017-06-08 |
| Howmedica Osteonics Corp | 510(k) number | 2011-08-17 | Not classified | Other | Two National Joint Registries suggest that the EIUS Unicompartmental System is associated with a higher revision rate then the unicompartmental devices. | 26,648 units | 2014-03-26 |
| Howmedica Osteonics Corp | 510(k) number | 2006-10-17 | Not classified | Other | Loose fixation pegs: One lot of femoral components may have loose fixation pegs. | 3 total, 2 in USA | 2009-07-07 |
| Howmedica Osteonics Corp | 510(k) number | 2006-10-05 | Not classified | Labeling mix-ups | Stryker Orthopaedics became aware that a box labeled as Duracon Total Knee Distal Femoral Locking Screws for 5 mm spacer, may actually contain a 10 mm screw. | 7 units | 2010-10-07 |
| Howmedica Osteonics Corp | 510(k) number | 2006-05-05 | Not classified | Labeling mix-ups | A box packaged and labeled as a Duracon Total Knee Duration A-P Lipped Tibial Insert 11MM may actually contain a 9MM insert. | 8 | 2009-07-07 |
Recalls
26 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 |
|---|---|---|---|---|
| 2026-07-30 | Not classified | Process change control | Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to | 12,156 US |
| 2024-09-04 | Class II | Process control | Anterior locking tabs on the Triathlon Universal Baseplate are out of specification which may prevent engagement of either of the two locking tabs with the locking wire of the tibial insert. | 16 units |
| 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | 4 units |
| 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | |
| 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | |
| 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | 76 units US; |
| 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | |
| 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | |
| 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | |
| 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | |
| 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | 143 units US; 290 units OUS |
| 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | |
| 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | 16 units US; 56 units OUS |
| 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | |
| 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | |
| 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | |
| 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | 36 units US |
| 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | 269 units US; 307 units OUS |
| 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | 9 units US |
| 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | 5 units US |
| 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | 52 units US; 20 units OUS |
| 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | 70 units US |
| 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | 61 units US; 46 units OUS |
| 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | 192 units US |
| 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | |
| 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | |
| 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. |
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.