Injector, Vertebroplasty (does Not Contain Cement)
Orthopedic · 21 CFR 888.4200
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).
Recent MDR events
188 adverse event reports on file
- 11G IVAS ACCESS CANNULAJul 22, 2026MalfunctionStryker Instruments-a Division Of Stryker Corp3015967359-2026-99357
- 11G IVAS ACCESS CANNULAJun 30, 2026MalfunctionStryker Instruments-a Division Of Stryker Corp3015967359-2026-00438
- 11G IVAS ACCESS CANNULAJun 22, 2026InjuryStryker Instruments-a Division Of Stryker Corp3015967359-2026-00432
- EASYNJECTMay 21, 2026InjuryBiopsybell Srl3003272754-2026-00001
- 11G IVAS ACCESS CANNULAMay 12, 2026MalfunctionStryker Instruments-a Division Of Stryker Corp3015967359-2026-00327
- 11G IVAS ACCESS CANNULAApr 22, 2026MalfunctionStryker Instruments-a Division Of Stryker Corp3015967359-2026-99204
- 11G VERTEPORT CEMENT CANNULA (18/PKG)Apr 22, 2026MalfunctionStryker Instruments-a Division Of Stryker Corp3015967359-2026-99222
- AVAFLEX CURVED NEEDLE W/O CANNULAApr 22, 2026MalfunctionStryker Instruments-a Division Of Stryker Corp3015967359-2026-99247
- AVAFLEX CURVED NEEDLE W/ CANNULAApr 22, 2026MalfunctionStryker Instruments-a Division Of Stryker Corp3015967359-2026-99266
- IVASMar 24, 2026MalfunctionStryker Corporation24673360
Event type breakdown
Recalls
26 recall events for this product code
- Merit Medical Systems, Inc.Open, ClassifiedOct 11, 2024
StabiliT TOUCH Syringe, REF: IN8VCF/B
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 could lead to infection.
Z-0073-2025 · View FDA record ↗ - Stryker CorporationOpen, ClassifiedJul 3, 2024
Curved, super elastic cement delivery needle that passes through the cannula in a straight configuration and enters the vertebral body in a curved configuration
Expired Products distributed to customers
Z-2260-2024 · View FDA record ↗ - Synthes USA HQ, Inc.TerminatedNov 27, 2013
Vertebroplasty Needle Kit 10g Diamond Tip
Complaints were received of inconsistencies in the expiration dates shown on the packaging of the Vertebroplasty Needle Kit 10g Diamond Tip device.
Z-0410-2014 · View FDA record ↗ - Orthovita, Inc., dBA Stryker Orthobiologics.TerminatedMay 24, 2013
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger Delivery System, 4", Part Number 2090-0502
There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bending of the catheter during the retraction from the needle. It was determined to be use errors. The correction is limited to a revision of the Directions for Use.
Z-1387-2013 · View FDA record ↗ - Orthovita, Inc., dBA Stryker Orthobiologics.TerminatedMay 24, 2013
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger Delivery System, 6", Part Number 2090-0505
There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bending of the catheter during the retraction from the needle. It was determined to be use errors. The correction is limited to a revision of the Directions for Use.
Z-1388-2013 · View FDA record ↗ - Orthovita, Inc., dBA Stryker Orthobiologics.TerminatedMay 24, 2013
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger Delivery System, 4", Part Number 2090-0501
There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bending of the catheter during the retraction from the needle. It was determined to be use errors. The correction is limited to a revision of the Directions for Use.
Z-1389-2013 · View FDA record ↗ - Orthovita, Inc., dBA Stryker Orthobiologics.TerminatedMay 24, 2013
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Syringe Delivery System, 6", Part Number 2090-0504
There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bending of the catheter during the retraction from the needle. It was determined to be use errors. The correction is limited to a revision of the Directions for Use.
Z-1390-2013 · View FDA record ↗ - Orthovita, Inc., dBA Stryker Orthobiologics.TerminatedMay 24, 2013
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Beveled Needle, 4", Part Number 2110-0505
There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bending of the catheter during the retraction from the needle. It was determined to be use errors. The correction is limited to a revision of the Directions for Use.
Z-1391-2013 · View FDA record ↗ - Orthovita, Inc., dBA Stryker Orthobiologics.TerminatedMay 24, 2013
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Catheter, 8", Part Number 2110-0526
There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bending of the catheter during the retraction from the needle. It was determined to be use errors. The correction is limited to a revision of the Directions for Use.
Z-1392-2013 · View FDA record ↗ - Orthovita, Inc., dBA Stryker Orthobiologics.TerminatedMay 24, 2013
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger, 6", Part Number 2110-0501
There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bending of the catheter during the retraction from the needle. It was determined to be use errors. The correction is limited to a revision of the Directions for Use.
Z-1393-2013 · View FDA record ↗
Registered firms
72 firms currently registered for this product code
Sterigenics U.s., Llc
Salt Lake City, UT, US
Midwest Sterilization Corp.
JACKSON, MO, US
Synergy Health Sterilisation Uk Ltd
Thorne Doncaster, GB
Stryker Puerto Rico, Llc.
ARROYO, PR, US
Thiebaud Sas
Paris Ile-de-France, FR
Zavation
Flowood, MS, US
Medacta International Sa
Castel San Pietro Ticino, CH
Top Clean Injection
PESCHADOIRES Puy-de-Dome, FR
Merit Medical Australia Pty Ltd.
Braiside Victoria, AU
Synthes Gmbh
Selzach Solothurn, CH
Synergy Health Ede Bv
Ede Gelderland, NL
Stryker Instruments
Portage, MI, US
Amnotec International Medical Gmbh
Neuhausen ob Eck Baden-Wurttemberg, DE
Izi Medical Products Llc
Owings Mills, MD, US
L Z Form Kft
Ajka Veszprem, HU
Shanghai Lange Medtech Co., Ltd.
Shanghai, CN
Medyssey Co., Ltd.
Jecheon-si Chungbuk, KR
Medxl
ARDMORE, OK, US
Jiangsu Changmei Medtech Co.,ltd
Changzhou Jiangsu, CN
Synergy Health Ede Bv
Venlo Limburg, NL
Trokamed Gmbh
GEISINGEN Baden-Wurttemberg, DE
Sterigenics U.s. Llc
Hayward, CA, US
Merit Maquiladora Mexico, S. De R.l. De C.v.
Tijuana Baja California, MX
Highridge Medical, Llc
Westminster, CO, US
Steris Isomedix Puerto Rico, Inc.
Alts De Cerro Gordo 3&4, PR, US
510(k) clearances
1 clearances for this product code