Home › Device types › OAR
Injector, Vertebroplasty (Does Not Contain Cement)
FDA product code OAR · Class 1 · Orthopedic
185
Registered devices
191
Adverse events
26
Recalls
1
510(k) clearances
Devices with this code
Aliquot — Stryker CorporationAVAflex — CAREFUSION 2200, INCPCD — STRYKER CORPORATIONNA — STRYKER CORPORATIONK2M Fenestrated Tap System — VB Spine LLCiVAS — STRYKER CORPORATIONBIOPSYBELL — BIOPSYBELL SRLGun-shaped Bone Cement Filler Devices — Shanghai Lange Medtech Co., Ltd.BIOPSYBELL — BIOPSYBELL SRLDFINE® — Merit Medical Systems, Inc.VertePort — STRYKER CORPORATIONPURE KIT — TEKNIMEDBIOPSYBELL — BIOPSYBELL SRLACM — STRYKER CORPORATIONVCF-200 — Izi Medical Products, LLCInvictus® Spinal Cement System — TEKNIMEDMEDINAUT-V — IMEDICOM CO., LTD.VCF-300 — Izi Medical Products, LLCDynamo — TEKNIMEDDynamo — TEKNIMEDPureKit Syringe 1.5cc MV — TEKNIMEDVERTECEM II — Synthes GmbHAliquot — Stryker CorporationRevolution — 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 |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.