Affixus® Hip Fracture Nail
181 catalogue numbers from 8143-09-180, listed by Biomet Orthopedics, United States, under Rod, Fixation, Intramedullary And Accessories. 17 manufacturers in China are registered for this product code.
17manufacturers in China registered for this device type
181catalogue numbers in this listing
4510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (7), Shanghai (3), Zhejiang (3). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
Showing 12 of 17. All 17 manufacturers in China registered for Rod, Fixation, Intramedullary And Accessories
Record
| Listed by | Biomet Orthopedics, United States |
|---|---|
| FDA product code | HSB |
| Device type | Rod, Fixation, Intramedullary And Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3020 |
| 510(k) | K100238 |
| Record published | 2023-06-13 |
| Record revised | 2025-05-30 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8143-09-180 | 125° 9 mm X 180 mm | In distribution |
| 8144-11-400 | 125° 11 mm X 400 mm | In distribution |
| 8143-11-440 | 125° 11 mm X 440 mm | In distribution |
| 8145-11-300 | 130° 11 mm X 300 mm | In distribution |
| 8144-13-300 | 125° 13 mm X 300 mm | In distribution |
| 8145-01-075 | 75 mm | In distribution |
| 8145-11-420 | 130° 11 mm X 420 mm | In distribution |
| 8146-15-320 | 130° 15 mm X 320 mm | In distribution |
| 8146-15-400 | 130° 15 mm X 400 mm | In distribution |
| 8144-09-460 | 125° 9 mm X 460 mm | In distribution |
| 8145-13-460 | 130° 13 mm X 460 mm | In distribution |
| 8143-09-360 | 125° 9 mm X 360 mm | In distribution |
| 8144-11-460 | 125° 11 mm X 460 mm | In distribution |
| 8145-01-085 | 85 mm | In distribution |
| 8145-09-180 | 130° 9 mm X 180 mm | In distribution |
| 8143-13-180 | 125° 13 mm X 180 mm | In distribution |
| 8145-13-440 | 130° 13 mm X 440 mm | In distribution |
| 8144-11-280 | 125° 11 mm X 280 mm | In distribution |
| 8146-11-260 | 130° 11 mm X 260 mm | In distribution |
| 8144-13-420 | 125° 13 mm X 420 mm | In distribution |
| 8145-01-100 | 100 mm | In distribution |
| 8146-13-460 | 130° 13 mm X 460 mm | In distribution |
| 8144-13-400 | 125° 13 mm X 400 mm | In distribution |
| 8145-11-180 | 130° 11 mm X 180 mm | In distribution |
| 8146-13-320 | 130° 13 mm X 320 mm | In distribution |
| 8144-09-380 | 125° 9 mm X 380 mm | In distribution |
| 8144-11-300 | 125° 11 mm X 300 mm | In distribution |
| 8143-09-260 | 125° 9 mm X 260 mm | In distribution |
| 8145-01-050 | 50 mm | In distribution |
| 8146-09-260 | 130° 9 mm X 260 mm | In distribution |
| 8143-11-180 | 125° 11MM X 180MM | In distribution |
| 8146-15-360 | 130° 15 mm X 360 mm | In distribution |
| 8143-11-340 | 125° 11 mm X 340 mm | In distribution |
| 8146-13-380 | 130° 13 mm X 380 mm | In distribution |
| 8144-11-380 | 125° 11 mm X 380 mm | In distribution |
| 8143-13-320 | 125° 13 mm X 320 mm | In distribution |
| 8144-09-300 | 125° 9 mm X 300 mm | In distribution |
| 8145-09-380 | 130° 9 mm X 380 mm | In distribution |
| 8145-09-440 | 130° 9 mm X 440 mm | In distribution |
| 8146-11-400 | 130° 11 mm X 400 mm | In distribution |
| 8143-09-460 | 125° 9 mm X 460 mm | In distribution |
| 8146-09-440 | 130° 9 mm X 440 mm | In distribution |
| 8145-09-280 | 130° 9 mm X 280 mm | In distribution |
| 8146-09-460 | 130° 9 mm X 460 mm | In distribution |
| 8145-09-460 | 130° 9 mm X 460 mm | In distribution |
| 8145-11-320 | 130° 11 mm X 320 mm | In distribution |
| 8145-13-260 | 130° 13 mm X 260 mm | In distribution |
| 8145-11-460 | 130° 11 mm X 460 mm | In distribution |
| 8145-09-360 | 130° 9 mm X 360 mm | In distribution |
| 8146-11-320 | 130° 11 mm X 320 mm | In distribution |
| 8146-09-340 | 130° 9 mm X 340 mm | In distribution |
| 8144-09-440 | 125° 9 mm X 440 mm | In distribution |
| 8145-13-320 | 130° 13 mm X 320 mm | In distribution |
| 8146-11-380 | 130° 11 mm X 380 mm | In distribution |
| 8146-13-260 | 130° 13 mm X 260 mm | In distribution |
| 8143-13-460 | 125° 13 mm X 460 mm | In distribution |
| 8146-09-420 | 130° 9 mm X 420 mm | In distribution |
| 8143-09-380 | 125° 9 mm X 380 mm | In distribution |
| 8145-10-085 | 10.5 mm X 85 mm | In distribution |
| 8146-11-360 | 130° 11 mm X 360 mm | In distribution |
| 8145-11-440 | 130° 11 mm X 440 mm | In distribution |
| 8146-13-420 | 130° 13 mm X 420 mm | In distribution |
| 8145-01-060 | 60 mm | In distribution |
| 8146-11-460 | 130° 11 mm X 460 mm | In distribution |
| 8146-13-400 | 130° 13 mm X 400 mm | In distribution |
| 8143-13-440 | 125° 13 mm X 440 mm | In distribution |
| 8143-11-180 | 125° 11 mm X 180 mm | In distribution |
| 8143-11-280 | 125° 11 mm X 280 mm | In distribution |
| 8145-11-340 | 130° 11 mm X 340 mm | In distribution |
| 8145-03-005 | 5 mm | In distribution |
| 8143-13-340 | 125° 13 mm X 340 mm | In distribution |
| 8145-10-090 | 10.5 mm X 90 mm | In distribution |
| 8143-11-400 | 125° 11 mm X 400 mm | In distribution |
| 8145-11-280 | 130° 11 mm X 280 mm | In distribution |
| 8143-09-320 | 125° 9 mm X 320 mm | In distribution |
| 8145-09-400 | 130° 9 mm X 400 mm | In distribution |
| 8143-13-300 | 125° 13 mm X 300 mm | In distribution |
| 8144-13-360 | 125° 13 mm X 360 mm | In distribution |
| 8146-09-300 | 130° 9 mm X 300 mm | In distribution |
| 8143-11-460 | 125° 11 mm X 460 mm | In distribution |
| 8145-15-440 | 130° 15 mm X 440 mm | In distribution |
| 8145-15-400 | 130° 15 mm X 400 mm | In distribution |
| 8143-11-320 | 125° 11 mm X 320 mm | In distribution |
| 8143-11-420 | 125° 11 mm X 420 mm | In distribution |
| 8145-03-101 | In distribution | |
| 8143-11-300 | 125° 11 mm X 300 mm | In distribution |
| 8143-13-360 | 125° 13 mm X 360 mm | In distribution |
| 8144-13-440 | 125° 13 mm X 440 mm | In distribution |
| 8145-09-320 | 130° 9 mm X 320 mm | In distribution |
| 8145-01-090 | 90 mm | In distribution |
| 8144-13-260 | 125° 13 mm X 260 mm | In distribution |
| 8145-10-120 | 10.5 mm X 120 mm | In distribution |
| 8144-09-260 | 125° 9 mm X 260 mm | In distribution |
| 8144-13-280 | 125° 13 mm X 280 mm | In distribution |
| 8143-09-180 | 125° 9MM X 180MM | In distribution |
| 8145-01-080 | 80 mm | In distribution |
| 8143-09-400 | 125° 9 mm X 400 mm | In distribution |
| 8143-11-360 | 125° 11 mm X 360 mm | In distribution |
| 8146-15-440 | 130° 15 mm X 440 mm | In distribution |
| 8144-09-280 | 125° 9 mm X 280 mm | In distribution |
| 8143-11-260 | 125° 11 mm X 260 mm | In distribution |
| 8145-13-340 | 130° 13 mm X 340 mm | In distribution |
| 8143-13-260 | 125° 13 mm X 260 mm | In distribution |
| 8145-03-000 | In distribution | |
| 8146-11-280 | 130° 11 mm X 280 mm | In distribution |
| 8145-10-115 | 10.5 mm X 115 mm | In distribution |
| 8144-09-340 | 125° 9 mm X 340 mm | In distribution |
| 8146-13-360 | 130° 13 mm X 360 mm | In distribution |
| 8145-09-180 | 130° 9MM X 180MM | In distribution |
| 8145-01-105 | 105 mm | In distribution |
| 8145-10-095 | 10.5 mm X 95 mm | In distribution |
| 8145-10-100 | 10.5 mm X 100 mm | In distribution |
| 8145-10-070 | 10.5 mm X 70 mm | In distribution |
| 8145-13-180 | 130° 13 mm X 180 mm | In distribution |
| 8144-11-360 | 125° 11 mm X 360 mm | In distribution |
| 8145-15-320 | 130° 15 mm X 320 mm | In distribution |
| 8144-13-340 | 125° 13 mm X 340 mm | In distribution |
| 8145-10-110 | 10.5 mm X 110 mm | In distribution |
| 8143-13-380 | 125° 13 mm X 380 mm | In distribution |
| 8145-01-095 | 95 mm | In distribution |
| 8144-09-420 | 125° 9 mm X 420 mm | In distribution |
| 8144-13-380 | 125° 13 mm X 380 mm | In distribution |
| 8146-09-280 | 130° 9 mm X 280 mm | In distribution |
| 8145-10-125 | 10.5 mm X 125 mm | In distribution |
| 8146-13-440 | 130° 13 mm X 440 mm | In distribution |
| 8145-09-300 | 130° 9 mm X 300 mm | In distribution |
| 8146-11-440 | 130° 11 mm X 440 mm | In distribution |
| 8145-01-070 | 70 mm | In distribution |
| 8145-11-180 | 130° 11MM X 180MM | In distribution |
| 8145-11-400 | 130° 11 mm X 400 mm | In distribution |
| 8146-13-300 | 130° 13 mm X 300 mm | In distribution |
| 8145-11-260 | 130° 11 mm X 260 mm | In distribution |
| 8145-01-055 | 55 mm | In distribution |
| 8144-13-320 | 125° 13 mm X 320 mm | In distribution |
| 8146-09-380 | 130° 9 mm X 380 mm | In distribution |
| 8145-10-130 | 10.5 mm X 130 mm | In distribution |
| 8145-09-420 | 130° 9 mm X 420 mm | In distribution |
| 8146-09-400 | 130° 9 mm X 400 mm | In distribution |
| 8145-13-420 | 130° 13 mm X 420 mm | In distribution |
| 8143-13-400 | 125° 13 mm X 400 mm | In distribution |
| 8144-11-320 | 125° 11 mm X 320 mm | In distribution |
| 8144-09-400 | 125° 9 mm X 400 mm | In distribution |
| 8144-09-360 | 125° 9 mm X 360 mm | In distribution |
| 8143-13-280 | 125° 13 mm X 280 mm | In distribution |
| 8144-13-460 | 125° 13 mm X 460 mm | In distribution |
| 8145-13-280 | 130° 13 mm X 280 mm | In distribution |
| 8143-09-420 | 125° 9 mm X 420 mm | In distribution |
| 8144-11-420 | 125° 11 mm X 420 mm | In distribution |
| 8143-11-380 | 125° 11 mm X 380 mm | In distribution |
| 8143-09-440 | 125° 9 mm X 440 mm | In distribution |
| 8146-13-340 | 130° 13 mm X 340 mm | In distribution |
| 8143-13-420 | 125° 13 mm X 420 mm | In distribution |
| 8145-13-380 | 130° 13 mm X 380 mm | In distribution |
| 8145-01-110 | 110 mm | In distribution |
| 8146-09-320 | 130° 9 mm X 320 mm | In distribution |
| 8145-11-360 | 130° 11 mm X 360 mm | In distribution |
| 8145-09-260 | 130° 9 mm X 260 mm | In distribution |
| 8146-09-360 | 130° 9 mm X 360 mm | In distribution |
| 8145-10-105 | 10.5 mm X 105 mm | In distribution |
| 8143-09-280 | 125° 9 mm X 280 mm | In distribution |
| 8145-13-180 | 130° 13MM X 180MM | In distribution |
| 8145-15-360 | 130° 15 mm X 360 mm | In distribution |
| 8145-09-340 | 130° 9 mm X 340 mm | In distribution |
| 8146-11-300 | 130° 11 mm X 300 mm | In distribution |
| 8146-13-280 | 130° 13 mm X 280 mm | In distribution |
| 8144-11-440 | 125° 11 mm X 440 mm | In distribution |
| 8145-10-080 | 10.5 mm X 80 mm | In distribution |
| 8145-10-075 | 10.5 mm X 75 mm | In distribution |
| 8144-11-260 | 125° 11 mm X 260 mm | In distribution |
| 8143-13-180 | 125° 13MM X 180MM | In distribution |
| 8145-11-380 | 130° 11 mm X 380 mm | In distribution |
| 8146-11-340 | 130° 11 mm X 340 mm | In distribution |
| 8145-13-300 | 130° 13 mm X 300 mm | In distribution |
| 8146-11-420 | 130° 11 mm X 420 mm | In distribution |
| 8145-01-065 | 65 mm | In distribution |
| 8143-09-300 | 125° 9 mm X 300 mm | In distribution |
| 8143-09-340 | 125° 9 mm X 340 mm | In distribution |
| 8144-09-320 | 125° 9 mm X 320 mm | In distribution |
| 8145-13-400 | 130° 13 mm X 400 mm | In distribution |
| 8145-13-360 | 130° 13 mm X 360 mm | In distribution |
| 8144-11-340 | 125° 11 mm X 340 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| T2 | Stryker GmbH | 1,373 |
| Autobahn | Globus Medical, Inc. | 1,258 |
| Gamma | Stryker GmbH | 1,120 |
| Summa Orthopaedics Femur Nail System | Jeil Medical Corporation | 742 |
| Arix Femur Nail System | Jeil Medical Corporation | 742 |
| Orthofix | Orthofix SRL | 721 |
| Rod, Fixation, Intramedullary And Accessories | Synthes Gmbh | 715 |
| Trigen | Smith & Nephew, Inc. | 681 |
| Arthrex® | Arthrex, Inc. | 665 |
| Precice® Intramedullary Limb Lengthening System | NuVasive Specialized Orthopedics, Inc. | 596 |
| Apex | Orthoxel Designated Activity Company | 569 |
| Natural Nail® | Zimmer, Inc. | 552 |
Showing 12 of 2,207. All products under Rod, Fixation, Intramedullary And Accessories
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K070955 | 2007-10-12 |
| K013923 | 2002-02-25 |
| K002278 | 2000-10-23 |
| K002057 | 2000-10-04 |
Recalls Naming This Product
249 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 |
|---|---|---|---|---|---|---|---|
| Biomet, Inc. | 510(k) number | 2018-10-02 | Class II | Mixed-up of materials/components | The set screw is not able to advance or reverse from the original position in the nail. | 2,163 in total (expanded) | 2020-06-02 |
| Biomet, Inc. | 510(k) number | 2018-10-02 | Class II | Mixed-up of materials/components | The set screw is not able to advance or reverse from the original position in the nail. | 2,163 in total (expanded) | 2020-06-02 |
| Biomet, Inc. | 510(k) number | 2018-10-02 | Class II | Mixed-up of materials/components | The set screw is not able to advance or reverse from the original position in the nail. | 2,163 in total (expanded) | 2020-06-02 |
| Biomet, Inc. | 510(k) number | 2018-10-02 | Class II | Mixed-up of materials/components | The set screw is not able to advance or reverse from the original position in the nail. | 2,163 in total (expanded) | 2020-06-02 |
| Biomet, Inc. | 510(k) number | 2018-10-02 | Class II | Mixed-up of materials/components | The set screw is not able to advance or reverse from the original position in the nail. | 2,163 in total (expanded) | 2020-06-02 |
| Biomet, Inc. | 510(k) number | 2018-10-02 | Class II | Mixed-up of materials/components | The set screw is not able to advance or reverse from the original position in the nail. | 2,163 in total (expanded) | 2020-06-02 |
| Biomet, Inc. | 510(k) number | 2018-10-02 | Class II | Mixed-up of materials/components | The set screw is not able to advance or reverse from the original position in the nail. | 2,163 in total (expanded) | 2020-06-02 |
| Biomet, Inc. | 510(k) number | 2018-10-02 | Class II | Mixed-up of materials/components | The set screw is not able to advance or reverse from the original position in the nail. | 2,163 in total (expanded) | 2020-06-02 |
| Biomet, Inc. | 510(k) number | 2018-08-08 | Class II | Employee error | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. | 153 | 2020-07-30 |
| Biomet, Inc. | 510(k) number | 2018-08-08 | Class II | Employee error | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. | 24 | 2020-07-30 |
| Biomet, Inc. | 510(k) number | 2018-08-08 | Class II | Employee error | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. | 72 | 2020-07-30 |
| Biomet, Inc. | 510(k) number | 2018-08-08 | Class II | Employee error | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. | 38 | 2020-07-30 |
| Biomet, Inc. | 510(k) number | 2018-08-08 | Class II | Employee error | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. | 51 | 2020-07-30 |
| Biomet, Inc. | 510(k) number | 2018-08-08 | Class II | Employee error | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. | 19 | 2020-07-30 |
| Biomet, Inc. | 510(k) number | 2018-08-08 | Class II | Employee error | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. | 14 | 2020-07-30 |
| Biomet, Inc. | 510(k) number | 2018-08-08 | Class II | Employee error | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. | 20 | 2020-07-30 |
| Biomet, Inc. | 510(k) number | 2018-08-08 | Class II | Employee error | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. | 153 | 2020-07-30 |
| Biomet, Inc. | 510(k) number | 2018-08-08 | Class II | Employee error | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. | 27 | 2020-07-30 |
| Biomet, Inc. | 510(k) number | 2018-08-08 | Class II | Employee error | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. | 12 | 2020-07-30 |
| Biomet, Inc. | 510(k) number | 2018-08-08 | Class II | Employee error | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. | 20 | 2020-07-30 |
| Biomet, Inc. | 510(k) number | 2018-08-08 | Class II | Employee error | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. | 51 | 2020-07-30 |
| Biomet, Inc. | 510(k) number | 2018-08-08 | Class II | Employee error | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. | 20 | 2020-07-30 |
| Biomet, Inc. | 510(k) number | 2018-08-08 | Class II | Employee error | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. | 18 | 2020-07-30 |
| Biomet, Inc. | 510(k) number | 2018-08-08 | Class II | Employee error | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. | 34 | 2020-07-30 |
| Biomet, Inc. | 510(k) number | 2018-08-08 | Class II | Employee error | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. | 24 | 2020-07-30 |
| Biomet, Inc. | 510(k) number | 2018-08-08 | Class II | Employee error | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. | 22 | 2020-07-30 |
| Biomet, Inc. | 510(k) number | 2018-08-08 | Class II | Employee error | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. | 27 | 2020-07-30 |
| Biomet, Inc. | 510(k) number | 2018-08-08 | Class II | Employee error | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. | 9 | 2020-07-30 |
| Biomet, Inc. | 510(k) number | 2018-08-08 | Class II | Employee error | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. | 10 | 2020-07-30 |
| Biomet, Inc. | 510(k) number | 2018-08-08 | Class II | Employee error | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. | 25 | 2020-07-30 |
| Biomet, Inc. | 510(k) number | 2018-08-08 | Class II | Employee error | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. | 16 | 2020-07-30 |
| Biomet, Inc. | 510(k) number | 2018-08-08 | Class II | Employee error | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. | 78 | 2020-07-30 |
| Biomet, Inc. | 510(k) number | 2018-08-08 | Class II | Employee error | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. | 14 | 2020-07-30 |
| Biomet, Inc. | 510(k) number | 2018-08-08 | Class II | Employee error | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. | 29 | 2020-07-30 |
| Biomet, Inc. | 510(k) number | 2018-08-08 | Class II | Employee error | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. | 30 | 2020-07-30 |
| Biomet, Inc. | 510(k) number | 2018-08-08 | Class II | Employee error | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. | 33 | 2020-07-30 |
| Biomet, Inc. | 510(k) number | 2018-08-08 | Class II | Employee error | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. | 15 | 2020-07-30 |
| Biomet, Inc. | 510(k) number | 2018-08-08 | Class II | Employee error | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. | 60 | 2020-07-30 |
| Biomet, Inc. | 510(k) number | 2018-08-08 | Class II | Employee error | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. | 68 | 2020-07-30 |
| Biomet, Inc. | 510(k) number | 2018-08-08 | Class II | Employee error | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. | 16 | 2020-07-30 |
Showing 40 of 249.
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.