Home › Device types › OAR
Injector, Vertebroplasty (Does Not Contain Cement)
FDA product code OAR · Class 1 · Orthopedic
182
Registered devices
188
Adverse events
26
Recalls
1
510(k) clearances
Devices with this code
BIOPSYBELL — BIOPSYBELL SRLK2M Fenestrated Tap System — VB Spine LLCNA — STRYKER CORPORATIONVertePort X4 Manifold — STRYKER CORPORATIONINTROX® HighV spinal cement system — TEKNIMEDPCD — STRYKER CORPORATIONNA — STRYKER CORPORATIONKMC Bone Cement Delivery System — Shanghai Kinetic Medical Co., Ltd.NA — STRYKER CORPORATIONBIOPSYBELL — BIOPSYBELL SRLVCF-100-PL — Izi Medical Products, LLCStabiliT® — Merit Medical Systems, Inc.META+ System 1.5cc MV — TEKNIMEDKMC Bone Cement Delivery System — Shanghai Kinetic Medical Co., Ltd.MED V+ — TEKNIMEDSYNJECT — Synthes GmbHSYNJECT — Synthes GmbHMendec® Kypho Set Monolateral 10 mm — TECRES SPAKiva — BENVENUE MEDICAL, INC.iVAS — STRYKER CORPORATIONK2M Fenestrated Tap System — VB Spine LLCKMC Bone Cement Delivery System — Shanghai Kinetic Medical Co., Ltd.VertePort X4 Manifold — STRYKER CORPORATIONNA — STRYKER CORPORATION
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-08-19 | Merit Medical Systems, Inc. | Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which coul |
| 2024-06-03 | Stryker Corporation | Expired Products distributed to customers |
| 2020-02-13 | Merit Medical Systems, Inc. | Vertebral hydraulic assemblies has incorrect expiration date printed on the labels.The product's shelf-life is two (2) years, but the expiration date printed on |
| 2020-02-13 | Merit Medical Systems, Inc. | Vertebral hydraulic assemblies has incorrect expiration date printed on the labels.The product's shelf-life is two (2) years, but the expiration date printed on |
| 2017-12-06 | Medtronic Sofamor Danek USA Inc | Medtronic has discovered the directional arrow at the proximal end of the instrument may not correctly align with the cut out opening on the distal end of the i |
| 2017-11-09 | Stryker Instruments Div. of Stryker Corporation | Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates. |
| 2017-11-09 | Stryker Instruments Div. of Stryker Corporation | Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates. |
| 2017-05-17 | Medtronic Sofamor Danek USA Inc | The directional arrow at the proximal end of the instrument may not correctly align with the cutout opening on the distal end of the instrument. Using affected |
| 2013-07-30 | Synthes USA HQ, Inc. | Complaints were received of inconsistencies in the expiration dates shown on the packaging of the Vertebroplasty Needle Kit 10g Diamond Tip device. |
| 2012-11-10 | Orthovita, Inc., dBA Stryker Orthobiologics. | There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has bee |
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