Injector, Vertebroplasty (Does Not Contain Cement)
FDA product code OAR · Class I (low risk) · 21 CFR 888.4200 · Orthopedic
Intended for injection of vertebroplasty bone cement for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
1510(k) clearances
0PMA approvals
26recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K051820 | Parallax Ezflow Cement Delivery SystemOAR · Traditional | Arthrocare Corp. | 09/06/2005SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0073-2025 Class II | StabiliT TOUCH Syringe, REF: IN8VCF/BInflation devices may have a small hole in the sterile barrier of the device and use of affected devices may… | Merit Medical Systems, Inc. | 08/19/2024Open, Classified |
| Z-2260-2024 Class II | Curved, super elastic cement delivery needle that passes through the cannula in a…Expired Products distributed to customers | Stryker Corporation | 06/03/2024Open, Classified |
| Z-2068-2020 Class II | DFINE Vertebral Assemblies: Hydraulic-Master Syringe Assembly, StabiliT Vertebral…Vertebral hydraulic assemblies has incorrect expiration date printed on the labels.The product's shelf-life… | Merit Medical Systems, Inc. | 02/13/2020Terminated |
| Z-2067-2020 Class II | DFINE Vertebral Hydraulic Assemblies: Hydraulic Assembly, StabiliT Vertebral…Vertebral hydraulic assemblies has incorrect expiration date printed on the labels.The product's shelf-life… | Merit Medical Systems, Inc. | 02/13/2020Terminated |
| Z-0352-2018 Class II | Medtronic KYPHON(R) Express(TM) Directional Bone Filler Device, SIZE 2, REF FB, QTY 1…Medtronic has discovered the directional arrow at the proximal end of the instrument may not correctly align… | Medtronic Sofamor Danek USA Inc | 12/06/2017Terminated |
| Z-1249-2018 Class II | PCD Kit: Long 90, 13g Match-Ground w/ Bevel, Product Number: 0506-485-000, UDI:…Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates. | Stryker Instruments Div. of Stryker… | 11/09/2017Terminated |
| Z-1247-2018 Class II | 11g Verteport Cement Cannula (18/pkg), Product Number: 0306-511-000, UDI:…Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates. | Stryker Instruments Div. of Stryker… | 11/09/2017Terminated |
| Z-2247-2017 Class II | KYPHON(R) Directional Bone Filler Device, Size: 3, REF F04C, Rx Only, STERILE R.The directional arrow at the proximal end of the instrument may not correctly align with the cutout opening… | Medtronic Sofamor Danek USA Inc | 05/17/2017Terminated |
| Z-0410-2014 Class II | Vertebroplasty Needle Kit 10g Diamond Tip Intended to be used to inject PMMA cement into…Complaints were received of inconsistencies in the expiration dates shown on the packaging of the… | Synthes USA HQ, Inc. | 07/30/2013Terminated |
| Z-1399-2013 Class II | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot…There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the… | Orthovita, Inc., dBA Stryker Orthobiologics. | 11/10/2012Terminated |
| Z-1398-2013 Class II | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot…There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the… | Orthovita, Inc., dBA Stryker Orthobiologics. | 11/10/2012Terminated |
| Z-1397-2013 Class II | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot…There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the… | Orthovita, Inc., dBA Stryker Orthobiologics. | 11/10/2012Terminated |
| Z-1396-2013 Class II | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot…There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the… | Orthovita, Inc., dBA Stryker Orthobiologics. | 11/10/2012Terminated |
| Z-1395-2013 Class II | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot…There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the… | Orthovita, Inc., dBA Stryker Orthobiologics. | 11/10/2012Terminated |
| Z-1394-2013 Class II | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot…There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the… | Orthovita, Inc., dBA Stryker Orthobiologics. | 11/10/2012Terminated |
| Z-1393-2013 Class II | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot…There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the… | Orthovita, Inc., dBA Stryker Orthobiologics. | 11/10/2012Terminated |
| Z-1392-2013 Class II | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot…There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the… | Orthovita, Inc., dBA Stryker Orthobiologics. | 11/10/2012Terminated |
| Z-1391-2013 Class II | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot…There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the… | Orthovita, Inc., dBA Stryker Orthobiologics. | 11/10/2012Terminated |
| Z-1390-2013 Class II | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot…There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the… | Orthovita, Inc., dBA Stryker Orthobiologics. | 11/10/2012Terminated |
| Z-1389-2013 Class II | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot…There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the… | Orthovita, Inc., dBA Stryker Orthobiologics. | 11/10/2012Terminated |
| Z-1388-2013 Class II | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot…There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the… | Orthovita, Inc., dBA Stryker Orthobiologics. | 11/10/2012Terminated |
| Z-1387-2013 Class II | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot…There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the… | Orthovita, Inc., dBA Stryker Orthobiologics. | 11/10/2012Terminated |
| Z-1940-2012 Class II | Depuy Spine Side Fire Needles 13G X 4IN Side-Fire Needle, part of the Confidence Spinal…Additional Instructions for Use and Surgical Technique for the Confidence Needle due to reports of breakage… | DePuy Mitek, Inc., a Johnson & Johnson Co. | 05/04/2012Terminated |
| Z-1939-2012 Class II | Depuy Spine Side Fire Needles 11G X 6IN Side-Fire Needle, part of the Confidence Spinal…Additional Instructions for Use and Surgical Technique for the Confidence Needle due to reports of breakage… | DePuy Mitek, Inc., a Johnson & Johnson Co. | 05/04/2012Terminated |
| Z-1938-2012 Class II | Depuy Spine Side Fire Needles 11G X 4IN, part of the Confidence Spinal Cement System…Additional Instructions for Use and Surgical Technique for the Confidence Needle due to reports of breakage… | DePuy Mitek, Inc., a Johnson & Johnson Co. | 05/04/2012Terminated |
| Z-1937-2012 Class II | Depuy Spine Side Fire Needles 13G X 6IN, part of the Confidence Spinal Cement System…Additional Instructions for Use and Surgical Technique for the Confidence Needle due to reports of breakage… | DePuy Mitek, Inc., a Johnson & Johnson Co. | 05/04/2012Terminated |