Novation
Tapered Reamer, Zimmer Hudson, Novation 3°, Size 15
14manufacturers in China registered for this device type
317catalogue numbers in this listing
8510(k) clearances naming this product code
3recalls on this code
Who Else Makes It
Concentrated in Jiangsu (8), Shanghai (2), Zhejiang (2). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Xian Airfoil Technology Co., Ltd. | Xian | Shaanxi | Contract manufacturer | 8 |
| Lincotek (Wuxi) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 7 |
| b-ONE Medical (Beijing) Co., Ltd. | Beijing | Beijing | Contract manufacturer | 7 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
Showing 12 of 14. All 14 manufacturers in China registered for Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Record
| Listed by | Exactech, Inc., United States |
|---|---|
| FDA product code | MEH |
| Device type | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3353 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K070479 |
| Record published | 2015-08-10 |
| Record revised | 2025-09-03 (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, manufacturing date, serial number |
| Sizes | Outer diameter 40 to 68 mm; length 115 to 190 mm; lumen/inner diameter 22 to 40 mm; angle 3 ° |
| Distribution end date | 2024-06-13 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 180-12-52 | Group 2 | In distribution |
| 167-00-04 | In distribution | |
| 160-20-18 | Standard Offset | In distribution |
| 160-30-10 | Standard Offset | In distribution |
| 160-21-14 | Extended Offset | In distribution |
| 180-01-40 | Group 00 | In distribution |
| 160-00-14 | Standard Offset | In distribution |
| 138-32-53 | 10 degree face changing | In distribution |
| 180-10-54 | Group 2 | In distribution |
| 180-10-58 | Group 3 | In distribution |
| 160-20-17 | Standard Offset | In distribution |
| 160-20-16 | Standard Offset | In distribution |
| 160-01-18 | Extended Offset | In distribution |
| 138-22-70 | 10 degree face changing | In distribution |
| 130-32-44 | Size Group 4 | In distribution |
| 160-21-12 | Extended Offset | In distribution |
| 160-32-15 | STD OFFSET | In distribution |
| 180-03-62 | Group 4 | In distribution |
| 180-10-64 | Group 5 | In distribution |
| 180-13-66 | Group 5 | In distribution |
| 167-00-02 | In distribution | |
| 180-11-40 | Group 00 | In distribution |
| 160-23-13 | EXT OFFSET | In distribution |
| 180-12-64 | Group 5 | In distribution |
| 180-14-54 | Group 3 | In distribution |
| 180-00-64 | Group 5 | In distribution |
| 160-21-13 | Extended Offset | In distribution |
| 180-01-48 | Group 1 | In distribution |
| 167-00-03 | In distribution | |
| 164-02-15 | Extended Offset | In distribution |
| 164-02-14 | Extended Offset | In distribution |
| 164-11-11 | Standard Offset | In distribution |
| 164-01-17 | Standard Offset | In distribution |
| 160-11-15 | Extended Offset | In distribution |
| 180-03-52 | Group 2 | In distribution |
| 140-32-53 | Size Group 3 | In distribution |
| 164-02-13 | Extended Offset | In distribution |
| 180-10-44 | Group 0 | In distribution |
| 160-23-15 | EXT OFFSET | In distribution |
| 180-10-68 | Group 5 | In distribution |
| 180-00-42 | Group 00 | In distribution |
| 164-03-09 | Standard Offset | In distribution |
| 180-01-64 | Group 5 | In distribution |
| 180-10-50 | Group 1 | In distribution |
| 164-01-14 | Standard Offset | In distribution |
| 180-12-48 | Group 1 | In distribution |
| 160-21-15 | Extended Offset | In distribution |
| 167-02-00 | In distribution | |
| 180-03-68 | Group 5 | In distribution |
| 180-00-52 | Group 2 | In distribution |
| 160-10-14 | Standard Offset | In distribution |
| 160-32-13 | STD OFFSET | In distribution |
| 164-03-11 | Standard Offset | In distribution |
| 140-32-51 | Size Group 1 | In distribution |
| 164-01-13 | Standard Offset | In distribution |
| 160-10-09 | Standard Offset | In distribution |
| 160-11-12 | Extended Offset | In distribution |
| 160-21-09 | Extended Offset | In distribution |
| 160-31-17 | Extended Offset | In distribution |
| 167-00-00 | In distribution | |
| 160-00-17 | Standard Offset | In distribution |
| 160-11-10 | Extended Offset | In distribution |
| 180-00-40 | Group 00 | In distribution |
| 180-10-40 | Group 00 | In distribution |
| 160-01-17 | Extended Offset | In distribution |
| 160-01-11 | Extended Offset | In distribution |
| 160-31-09 | Extended Offset | In distribution |
| 160-30-12 | Standard Offset | In distribution |
| 161-02-11 | SIZE 11 | In distribution |
| 161-08-06 | 19/20 | In distribution |
| 164-13-12 | Standard Offset | In distribution |
| 180-10-62 | Group 4 | In distribution |
| 180-12-68 | Group 5 | In distribution |
| 160-33-15 | EXT OFFSET | In distribution |
| 180-00-50 | Group 1 | In distribution |
| 160-20-11 | Standard Offset | In distribution |
| 164-13-09 | Standard Offset | In distribution |
| 180-13-68 | Group 5 | In distribution |
| 164-02-08 | Extended Offset | In distribution |
| 180-00-62 | Group 4 | In distribution |
| 180-01-46 | Group 0 | In distribution |
| 161-02-18 | SIZE 18 | In distribution |
| 180-02-50 | Group 1 | In distribution |
| 161-07-15 | SIZE 17 | In distribution |
| 161-07-03 | SIZE 15 | In distribution |
| 160-00-13 | Standard Offset | In distribution |
| 160-30-18 | Standard Offset | In distribution |
| 180-12-60 | Group 4 | In distribution |
| 180-10-66 | Group 5 | In distribution |
| 180-10-56 | Group 3 | In distribution |
| 160-00-15 | Standard Offset | In distribution |
| 160-11-18 | Extended Offset | In distribution |
| 138-32-44 | 10 degree face changing | In distribution |
| 160-11-13 | Extended Offset | In distribution |
| 160-30-15 | Standard Offset | In distribution |
| 161-07-05 | SIZE 17 | In distribution |
| 164-03-18 | Standard Offset | In distribution |
| 160-23-17 | EXT OFFSET | In distribution |
| 161-09-15 | Reamer blade lead angle | In distribution |
| 180-01-60 | Group 4 | In distribution |
| 161-08-09 | Angle 3 ° | In distribution |
| 180-01-44 | Group 0 | In distribution |
| 160-11-16 | Extended Offset | In distribution |
| 164-13-10 | Standard Offset | In distribution |
| 180-03-56 | Group 3 | In distribution |
| 161-08-16 | SIZE 16 | In distribution |
| 164-03-13 | Standard Offset | In distribution |
| 160-31-11 | Extended Offset | In distribution |
| 180-00-68 | Group 5 | In distribution |
| 136-32-44 | +5 Lateralized | In distribution |
| 136-22-70 | +5 Lateralized | In distribution |
| 160-00-16 | Standard Offset | In distribution |
| 180-01-58 | Group 3 | In distribution |
| 164-13-08 | Standard Offset | In distribution |
| 140-36-55 | Size Group 5 | In distribution |
| 160-33-11 | EXT OFFSET | In distribution |
| 160-10-12 | Standard Offset | In distribution |
| 164-01-09 | Standard Offset | In distribution |
| 160-01-16 | Extended Offset | In distribution |
| 140-28-51 | Size Group 1 | In distribution |
| 180-03-54 | Group 2 | In distribution |
| 136-28-52 | +5 Lateralized | In distribution |
| 160-21-10 | Extended Offset | In distribution |
| 164-12-11 | Extended Offset | In distribution |
| 160-30-17 | Standard Offset | In distribution |
| 160-10-16 | Standard Offset | In distribution |
| 160-11-11 | Extended Offset | In distribution |
| 160-20-09 | Standard Offset | In distribution |
| 180-13-52 | Group 2 | In distribution |
| 180-01-54 | Group 2 | In distribution |
| 167-00-02 | In distribution | |
| 164-01-12 | Standard Offset | In distribution |
| 164-12-08 | Extended Offset | In distribution |
| 180-11-42 | Group 00 | In distribution |
| 160-10-17 | Standard Offset | In distribution |
| 160-01-12 | Extended Offset | In distribution |
| 180-10-48 | Group 1 | In distribution |
| 180-00-56 | Group 3 | In distribution |
| 140-36-53 | Size Group 3 | In distribution |
| 164-13-11 | Standard Offset | In distribution |
| 180-03-64 | Group 5 | In distribution |
| 180-12-54 | Group 2 | In distribution |
| 164-03-10 | Standard Offset | In distribution |
| 164-02-18 | Extended Offset | In distribution |
| 180-01-62 | Group 4 | In distribution |
| 180-13-64 | Group 5 | In distribution |
| 160-30-11 | Standard Offset | In distribution |
| 138-32-55 | 10 degree face changing | In distribution |
| 180-03-66 | Group 5 | In distribution |
| 160-31-15 | Extended Offset | In distribution |
| 136-28-50 | +5 Lateralized | In distribution |
| 180-12-56 | Group 3 | In distribution |
| 180-10-60 | Group 4 | In distribution |
| 160-31-13 | Extended Offset | In distribution |
| 160-31-12 | Extended Offset | In distribution |
| 164-11-12 | Standard Offset | In distribution |
| 180-12-58 | Group 3 | In distribution |
| 164-01-08 | Standard Offset | In distribution |
| 180-00-44 | Group 0 | In distribution |
| 180-00-46 | Group 0 | In distribution |
| 160-32-11 | STD OFFSET | In distribution |
| 180-04-54 | Group 3 | In distribution |
| 160-31-16 | Extended Offset | In distribution |
| 164-12-10 | Extended Offset | In distribution |
| 164-03-17 | Standard Offset | In distribution |
| 161-01-03 | In distribution | |
| 160-10-15 | Standard Offset | In distribution |
| 160-11-14 | Extended Offset | In distribution |
| 138-28-50 | 10 degree face changing | In distribution |
| 180-01-66 | Group 5 | In distribution |
| 164-02-12 | Extended Offset | In distribution |
| 167-01-00 | In distribution | |
| 132-32-44 | Lipped | In distribution |
| SPI-051234 | In distribution | |
| 180-01-56 | Group 3 | In distribution |
| 160-20-13 | Standard Offset | In distribution |
| 160-01-14 | Extended Offset | In distribution |
| 164-02-09 | Extended Offset | In distribution |
| 164-03-16 | Standard Offset | In distribution |
| 167-00-04 | In distribution | |
| 180-13-58 | Group 3 | In distribution |
| 160-20-14 | Standard Offset | In distribution |
| 180-01-52 | Group 2 | In distribution |
| 160-11-17 | Extended Offset | In distribution |
| 142-28-51 | Lipped | In distribution |
| 161-08-11 | Angle 3 ° | In distribution |
| 160-01-15 | Extended Offset | In distribution |
| 160-20-12 | Standard Offset | In distribution |
| 167-00-03 | In distribution | |
| 164-12-12 | Extended Offset | In distribution |
| 160-22-13 | STD OFFSET | In distribution |
| 180-13-54 | Group 2 | In distribution |
| 180-02-52 | Group 2 | In distribution |
| 160-31-10 | Extended Offset | In distribution |
| 180-01-50 | Group 1 | In distribution |
| 138-36-43 | 10 degree face changing | In distribution |
| 160-22-15 | STD OFFSET | In distribution |
| 160-10-18 | Standard Offset | In distribution |
| 161-07-01 | SIZE 13 | In distribution |
| 160-01-13 | Extended Offset | In distribution |
| 164-11-09 | Standard Offset | In distribution |
| 160-00-09 | Standard Offset | In distribution |
| 160-20-10 | Standard Offset | In distribution |
| 164-03-14 | Standard Offset | In distribution |
| 180-03-60 | Group 4 | In distribution |
| 160-32-17 | STD OFFSET | In distribution |
| 164-02-10 | Extended Offset | In distribution |
| 161-05-02 | SIZE 2 | In distribution |
| 180-01-42 | Group 00 | In distribution |
| 180-00-48 | Group 1 | In distribution |
| 180-13-62 | Group 4 | In distribution |
| 160-00-12 | Standard Offset | In distribution |
| 164-01-10 | Standard Offset | In distribution |
| 160-01-09 | Extended Offset | In distribution |
| 160-30-09 | Standard Offset | In distribution |
| 160-33-13 | EXT OFFSET | In distribution |
| 138-36-45 | 10 degree face changing | In distribution |
| 167-01-00 | In distribution | |
| 180-12-50 | Group 1 | In distribution |
| 160-30-13 | Standard Offset | In distribution |
| 164-01-16 | Standard Offset | In distribution |
| 140-40-54 | Size Group 4 | In distribution |
| 160-31-14 | Extended Offset | In distribution |
| 164-02-17 | Extended Offset | In distribution |
| 164-01-15 | Standard Offset | In distribution |
| 160-33-17 | EXT OFFSET | In distribution |
| 180-13-56 | Group 3 | In distribution |
| 140-22-70 | Size Group 00 | In distribution |
| 160-00-11 | Standard Offset | In distribution |
| 180-10-52 | Group 2 | In distribution |
| 180-12-66 | Group 5 | In distribution |
| 164-03-15 | Standard Offset | In distribution |
| 180-03-58 | Group 3 | In distribution |
| 164-02-11 | Extended Offset | In distribution |
| 164-11-08 | Standard Offset | In distribution |
| 180-12-62 | Group 4 | In distribution |
| 180-02-48 | Group 1 | In distribution |
| 138-32-42 | 10 degree face changing | In distribution |
| 164-12-09 | Extended Offset | In distribution |
| 160-31-18 | Extended Offset | In distribution |
| 160-30-14 | Standard Offset | In distribution |
| 160-10-13 | Standard Offset | In distribution |
| 180-13-60 | Group 4 | In distribution |
| 161-08-18 | Reamer blade lead angle | In distribution |
| 160-10-10 | Standard Offset | In distribution |
| 160-21-17 | Extended Offset | In distribution |
| 164-02-16 | Extended Offset | In distribution |
| 160-00-18 | Standard Offset | In distribution |
| 160-30-16 | Standard Offset | In distribution |
| 164-01-11 | Standard Offset | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Alteon | Exactech, Inc. | 326 |
| Pinnacle | Depuy Orthopaedics, Inc. | 305 |
| SP-CL Hip Stem | Waldemar Link GmbH & Co. KG | 219 |
| Emperion | Smith & Nephew, Inc. | 201 |
| MobileLink Acetabular Cup System | Waldemar Link GmbH & Co. KG | 154 |
| Instrument | Howmedica Osteonics Corp | 145 |
| Restoration | Howmedica Osteonics Corp | 144 |
| Mfinity Femoral System | Medacta International SA | 138 |
| Echelon | Smith & Nephew, Inc. | 134 |
| Trinity Acetabular Hip System | Corin Limited | 128 |
| Redapt | Smith & Nephew, Inc. | 127 |
| Esop® | Fournitures Hospitalieres Industrie | 120 |
Showing 12 of 805. All products under Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K243839 | 2025-03-10 |
| K162732 | 2017-04-26 |
| K153649 | 2016-08-31 |
| K113320 | 2012-03-16 |
| K080980 | 2008-05-06 |
| K040613 | 2004-06-04 |
| K000242 | 2000-02-16 |
| K990197 | 1999-02-04 |
Recalls Naming This Product
30 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 | 2024-12-31 | Class II | Nonconforming Material/Component | Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer. | 42 | |
| Exactech, Inc. | 510(k) number | 2024-12-31 | Class II | Nonconforming Material/Component | Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer. | 87 | |
| 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 | 2022-08-11 | Class II | Process control | Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear. | 58158 devices | |
| Exactech, Inc. | 510(k) number | 2022-08-11 | Class II | Process control | Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear. | 3793 devices | |
| Exactech, Inc. | 510(k) number | 2022-08-11 | Class II | Process control | Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear. | 17929 units | |
| Exactech, Inc. | 510(k) number | 2021-06-29 | Class II | Unknown/Undetermined by firm | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. | 89,050 total | |
| Exactech, Inc. | 510(k) number | 2021-06-29 | Class II | Unknown/Undetermined by firm | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. | 89,050 total | |
| Exactech, Inc. | 510(k) number | 2021-06-29 | Class II | Unknown/Undetermined by firm | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. | 89,050 total | |
| Exactech, Inc. | 510(k) number | 2021-06-29 | Class II | Unknown/Undetermined by firm | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. | 89,050 total | |
| Exactech, Inc. | 510(k) number | 2021-06-29 | Class II | Unknown/Undetermined by firm | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. | 89,050 total | |
| Exactech, Inc. | 510(k) number | 2021-06-29 | Class II | Unknown/Undetermined by firm | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. | 89,050 total | |
| Exactech, Inc. | 510(k) number | 2021-06-29 | Class II | Unknown/Undetermined by firm | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. | 89,050 total | |
| Exactech, Inc. | 510(k) number | 2021-06-29 | Class II | Unknown/Undetermined by firm | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. | 89,050 total | |
| Exactech, Inc. | 510(k) number | 2021-06-29 | Class II | Unknown/Undetermined by firm | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. | 89,050 total | |
| Exactech, Inc. | 510(k) number | 2021-06-29 | Class II | Unknown/Undetermined by firm | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. | 89,050 total | |
| Exactech, Inc. | 510(k) number | 2021-06-29 | Class II | Unknown/Undetermined by firm | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. | 89,050 total | |
| Exactech, Inc. | 510(k) number | 2021-06-29 | Class II | Unknown/Undetermined by firm | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. | 89,050 total | |
| Exactech, Inc. | 510(k) number | 2021-06-29 | Class II | Unknown/Undetermined by firm | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. | 89,050 total | |
| Exactech, Inc. | 510(k) number | 2021-06-29 | Class II | Unknown/Undetermined by firm | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. | 89,050 total | |
| Exactech, Inc. | 510(k) number | 2021-06-29 | Class II | Unknown/Undetermined by firm | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. | 89,050 total | |
| Exactech, Inc. | 510(k) number | 2021-06-29 | Class II | Unknown/Undetermined by firm | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. | 89,050 total | |
| Exactech, Inc. | 510(k) number | 2021-06-29 | Class II | Unknown/Undetermined by firm | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. | 89,050 total | |
| Exactech, Inc. | 510(k) number | 2021-06-29 | Class II | Unknown/Undetermined by firm | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. | 89,050 total | |
| Exactech, Inc. | 510(k) number | 2016-11-07 | Class II | Under Investigation by firm | Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies the devices as another. | 79 units | 2019-08-05 |
| Exactech, Inc. | 510(k) number | 2016-05-26 | Class II | Under Investigation by firm | Labeled with the incorrect Global Trade Item Number (GTIN). The GTIN on the label identifies the devices as another. | 8 units | 2019-07-26 |
| Exactech, Inc. | 510(k) number | 2016-05-26 | Class II | Under Investigation by firm | Labeled with the incorrect Global Trade Item Number (GTIN). The GTIN on the label identifies the devices as another. | 14 | 2019-07-26 |
| Exactech, Inc. | 510(k) number | 2015-09-23 | Class II | Under Investigation by firm | Eight (8) pieces did not receive the specified Hydroxyapatite (HA) coating. | 8 | 2017-03-01 |
| Exactech, Inc. | 510(k) number | 2012-11-05 | Class II | Labeling mix-ups | Recall of Novation Crown Cup Connection GXL Neutral Liners Catalog No. (130-32-53) and Novation Crown Cup Connection GXL + 5mm Lateralized Liners Catalog No. (136-32-53). Exactech discovered the device labeling was inadvertently transposed | 26 Units | 2013-12-24 |
| Exactech, Inc. | 510(k) number | 2012-11-05 | Class II | Labeling mix-ups | Recall of Novation Crown Cup Connection GXL Neutral Liners Catalog No. (130-32-53) and Novation Crown Cup Connection GXL + 5mm Lateralized Liners Catalog No. (136-32-53). Exactech discovered the device labeling was inadvertently transposed | 26 Units | 2013-12-24 |
Recalls
2 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 |
|---|---|---|---|---|---|
| 2022-08-11 | Class II | Process control | Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear. | 136 devices | |
| 2017-10-09 | Class II | Error in labeling | Wrong device description of the label identifying the implant | 34 | 2019-08-06 |
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.