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Zavation FDA Recalls
71 recalls on file across devices, 0 of them Class I and 0 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| 10G DIRECT SINGLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.Class IIMar 25, 2021Products distributed as sterile may not have been adequately |
| ZVplasty System, 15mm, Part# VCF-1015-1. For use in Orthopedic / spinal procedures.Class IIMar 25, 2021Products distributed as sterile may not have been adequately |
| 10G DIRECT SINGLE - ACCESS, CODE INTVM-DSBAK. For use in Orthopedic / spinal procedures.Class IIMar 25, 2021Products distributed as sterile may not have been adequately |
| 10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES, CODE: INTVM-SCDK. For use in Orthopedic / spinal procedures.Class IIMar 25, 2021Products distributed as sterile may not have been adequately |
| 10G DOUBLE CEMENT DELIVERY KIT (8 FILLERS). For use in Orthopedic / spinal procedures.Class IIMar 25, 2021Products distributed as sterile may not have been adequately |
| 10G DIRECT SINGLE - ACCESS, CODE: INTV-DWCb. For use in Orthopedic / spinal procedures.Class IIMar 25, 2021Products distributed as sterile may not have been adequately |
| ZVplasty Direct Access Beveled Tip Trocar, 10 Gauge, REF VCF-1022. For use in Orthopedic / spinal procedures.Class IIMar 25, 2021Products distributed as sterile may not have been adequately |
| ZVplasty 10G, FLEX KYPHOPLASTY, REF VCF-1015-FLEX. For use in Orthopedic / spinal procedures.Class IIMar 25, 2021Products distributed as sterile may not have been adequately |
| VERTEBREX SINGLE BALLOON KIT, REF VBRX-15-SBK-10. For use in Orthopedic / spinal procedures.Class IIMar 25, 2021Products distributed as sterile may not have been adequately |
| ZVplasty Unipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCG-SCDK. For use in Orthopedic / spinal procedures.Class IIMar 25, 2021Products distributed as sterile may not have been adequately |
| 10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), INTVM-DSSKBD. For use in Orthopedic / spinal procedures.Class IIMar 25, 2021Products distributed as sterile may not have been adequately |
| ZVplasty System, 15mm, Part Numbers: a) VCF-1015-2 b) VCF-1015-2A. For use in Orthopedic / spinal procedures.Class IIMar 25, 2021Products distributed as sterile may not have been adequately |
| 10G BEVELED TROCAR/CANNULA. For use in Orthopedic / spinal procedures.Class IIMar 25, 2021Products distributed as sterile may not have been adequately |
| 10G DIRECT DOUBLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.Class IIMar 25, 2021Products distributed as sterile may not have been adequately |
| InterV 11G Kyphoplasty Kit, REF Numbers: a) INTVMN-10-DSK b) INTVMN-15-DSK c) INTVMN-15-DSKC d) INTVMN-20-DSK. FClass IIMar 25, 2021Products distributed as sterile may not have been adequately |
| ZVplasty, Bipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCF-DCDK. For use in Orthopedic / spinal procedures.Class IIMar 25, 2021Products distributed as sterile may not have been adequately |
| 10 GAUGE CEMENT DELIVERY CANNULA, CODE: INTVM-CDC. For use in Orthopedic / spinal procedures.Class IIMar 25, 2021Products distributed as sterile may not have been adequately |
| 10G SINGLE CEMENT DELIVERY KIT (5 FILLERS). For use in Orthopedic / spinal procedures.Class IIMar 25, 2021Products distributed as sterile may not have been adequately |
| 10G COAXIAL CANNULA WITH TUOHY CONNECTION STERILE. For use in Orthopedic / spinal procedures.Class IIMar 25, 2021Products distributed as sterile may not have been adequately |
| ZVplasty System, 10mm, Pat# VCF-1010-2. For use in Orthopedic / spinal procedures.Class IIMar 25, 2021Products distributed as sterile may not have been adequately |
| ZVplasty Direct Bipedicular Bone Access Kit with Drill, 11 Gauge, REF VCF-DDBAK-11. For use in Orthopedic / spinal procClass IIMar 25, 2021Products distributed as sterile may not have been adequately |
| ZVplasty 10G, 15mm Single Balloon Kit, REF VCF-SBK. For use in Orthopedic / spinal procedures.Class IIMar 25, 2021Products distributed as sterile may not have been adequately |
| InterV 10G Bone Access Tools/Kit, REF INTVM-FLNK. For use in Orthopedic / spinal procedures.Class IIMar 25, 2021Products distributed as sterile may not have been adequately |
| ZVplasty Direct Access Diamond Tip Trocar, 10 Gauge, REF VCF-1023. For use in Orthopedic / spinal procedures.Class IIMar 25, 2021Products distributed as sterile may not have been adequately |
| ZVplasty Direct Access Diamond Tip Trocar, 11 Gauge, REF VCF-1023-11. For use in Orthopedic / spinal procedures.Class IIMar 25, 2021Products distributed as sterile may not have been adequately |
| 11G DIAMOND TROCAR/CANNULA. For use in Orthopedic / spinal procedures.Class IIMar 25, 2021Products distributed as sterile may not have been adequately |
| InterV CurvePlus Kit, REF Numbers: a) INTVMC-15-FLDSK b) INTVMC-20-FLDSK. For use in Orthopedic / spinal procedures.Class IIMar 25, 2021Products distributed as sterile may not have been adequately |
| 10G DIRECT DOUBLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.Class IIMar 25, 2021Products distributed as sterile may not have been adequately |
| InterV, 10G Kyphoplasty Kits, REF numbers: a) INTVM-10-DSK b) INTVM-10-SBK c) INTVM-15-DSK d) INTVM-15-DSKC e) INTVClass IIMar 25, 2021Products distributed as sterile may not have been adequately |
| 10 GAUGE CEMENT DELIVERY CANNULA, INTVM-CDC. For use in Orthopedic / spinal procedures.Class IIMar 25, 2021Products distributed as sterile may not have been adequately |
| ZVplasty Direct Access Bevel Tip Trocar, 11 Gauge, REF VCF-1022-11. For use in Orthopedic / spinal procedures.Class IIMar 25, 2021Products distributed as sterile may not have been adequately |
| OsteoFlex Cement and Mixing System, REF VCF-OSFL. For use in Orthopedic / spinal procedures.Class IIMar 25, 2021Products distributed as sterile may not have been adequately |
| 11G DIRECT SINGLE - DELIVERY (4 FILLERS-4 SYRINGES) CODE: INTVMN-SCDK. For use in Orthopedic / spinal procedures.Class IIMar 25, 2021Products distributed as sterile may not have been adequately |
| ZVplasty Unipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCF-SCDK. For use in Orthopedic / spinal procedures.Class IIMar 25, 2021Products distributed as sterile may not have been adequately |
| ZVplasty Directional Cement Cannula (4 pieces per pack), REF VCF-1080-S4. For use in Orthopedic / spinal procedures.Class IIMar 25, 2021Products distributed as sterile may not have been adequately |
| 10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES STERILE. For use in Orthopedic / spinal procedures.Class IIMar 25, 2021Products distributed as sterile may not have been adequately |
| ZVplasty Bipedicular Cement Delivery Cannula, 11 Gauge, REF VCF-DCDK-11. For use in Orthopedic / spinal procedures.Class IIMar 25, 2021Products distributed as sterile may not have been adequately |
| ZVplasty System, 15mm, Part# VCF-1015-1. For use in Orthopedic / spinal procedures.Class IIMar 25, 2021Products distributed as sterile may not have been adequately |
| 11G DIRECT DOUBLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.Class IIMar 25, 2021Products distributed as sterile may not have been adequately |
| 10 Gauge Drill, CODE: INTVM-DRL. For use in Orthopedic / spinal procedures.Class IIMar 25, 2021Products distributed as sterile may not have been adequately |
| ZVplasty Direct Bipedicular Bone Access Kit with Drill, 10 Gauge, VCF-DDBAK. For use in Orthopedic / spinal procedures.Class IIMar 25, 2021Products distributed as sterile may not have been adequately |
| 11G DIRECT WORKING CANNULA DIAMOND TIP MINI, CODE: INTVMN-DWCD. For use in Orthopedic / spinal procedures.Class IIMar 25, 2021Products distributed as sterile may not have been adequately |
| 10G CEMENT DELIVERY CANNULA. For use in Orthopedic / spinal procedures.Class IIMar 25, 2021Products distributed as sterile may not have been adequately |
| InterV, 10G FLEX Kyphoplasty, REF Number: a) INTVM-15-FLDSK b) INTVM-20-FLDSK. For use in Orthopedic / spinal proceClass IIMar 25, 2021Products distributed as sterile may not have been adequately |
| 10 GAUGE DIRECT UNILATERAL STYLET (1 X DIAMOND 1 X BEVEL) STERILE. For use in Orthopedic / spinal procedures.Class IIMar 25, 2021Products distributed as sterile may not have been adequately |
| ZVplasty, 10G, 10mm Double Balloon Kit, REF VCF-1010-DBK. For use in Orthopedic / spinal procedures.Class IIMar 25, 2021Products distributed as sterile may not have been adequately |
| ZVplasty Drill, 10 Gauge, REF VCF-1006. For use in Orthopedic / spinal procedures.Class IIMar 25, 2021Products distributed as sterile may not have been adequately |
| 11G BEVELED TROCAR/CANNULA. For use in Orthopedic / spinal procedures.Class IIMar 25, 2021Products distributed as sterile may not have been adequately |
| ZVplasty Direct Access Diamond Tip Trocar, 11 Gauge, REF VCF-1023-11. For use in Orthopedic / spinal procedures.Class IIMar 25, 2021Products distributed as sterile may not have been adequately |
| ZVPlasty, 11G, 15mm Traditional Bipedicular Kit, REF VCF-1115-2. For use in Orthopedic / spinal procedures.Class IIMar 25, 2021Products distributed as sterile may not have been adequately |
| VERTEBREX SINGLE BALLOON KIT, REF VBRX-20-SBK-10. For use in Orthopedic / spinal procedures.Class IIMar 25, 2021Products distributed as sterile may not have been adequately |
| 10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), CODE INTVM-DSSKbd. For use in Orthopedic / spinal procedures.Class IIMar 25, 2021Products distributed as sterile may not have been adequately |
| ZVplasty Direct Access Bevel Tip Trocar, 11 Gauge, REF VCF-1022-11. For use in Orthopedic / spinal procedures.Class IIMar 25, 2021Products distributed as sterile may not have been adequately |
| CEMIX - CEMENT MIXING SYSTEM STERILE, CODE INTV-MMS. For use in Orthopedic / spinal procedures.Class IIMar 25, 2021Products distributed as sterile may not have been adequately |
| 10G SINGLE CEMENT DELIVERY KIT (5 FILLERS). For use in Orthopedic / spinal procedures.Class IIMar 25, 2021Products distributed as sterile may not have been adequately |
| ZVplasty 10G, 20mm, Traditional Unipedicular Kit, REF VCF-1020-1. For use in Orthopedic / spinal procedures.Class IIMar 25, 2021Products distributed as sterile may not have been adequately |
| ZVplasty Directional Cement Cannula Long, REF VCF-1080-L. For use in Orthopedic / spinal procedures.Class IIMar 25, 2021Products distributed as sterile may not have been adequately |
| 10 GAUGE DRILL STERILE. For use in Orthopedic / spinal procedures.Class IIMar 25, 2021Products distributed as sterile may not have been adequately |
| ZVplasty 10G, 15mm, Additional Level Kit, REF VCF-1015-1A. For use in Orthopedic / spinal procedures.Class IIMar 25, 2021Products distributed as sterile may not have been adequately |
| 10G DIRECT SINGLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.Class IIMar 25, 2021Products distributed as sterile may not have been adequately |
| ZVplasty Biopsy Device, 10 Gauge, REF VCF-1010. For use in Orthopedic / spinal procedures.Class IIMar 25, 2021Products distributed as sterile may not have been adequately |
| OsteoFlex BONE CEMENT, REF Numbers: a) INTV-OSFL b) INTV-OSFL-LV. For use in Orthopedic / spinal procedures.Class IIMar 25, 2021Products distributed as sterile may not have been adequately |
| ZVplasty Direct Unipedicular Bone Access Kit with Drill, 10 Gauge, REF VCF-DSBAK. For use in Orthopedic / spinal procedClass IIMar 25, 2021Products distributed as sterile may not have been adequately |
| 10 GAUGE DIRECT ACCESS DIAMOND TIP, CODE: INTVM-DWCd. For use in Orthopedic / spinal procedures.Class IIMar 25, 2021Products distributed as sterile may not have been adequately |
| ZVplasty System, 20mm, Part# VCF-1020-2. For use in Orthopedic / spinal procedures.Class IIMar 25, 2021Products distributed as sterile may not have been adequately |
| ZVplasty Direct Bipedicular Bone Access Kit with Drill, 11 Gauge, REF VCF-DDBAK-11. For use in Orthopedic / spinal procClass IIMar 25, 2021Products distributed as sterile may not have been adequately |
| 10 G Coxaxial Cannula with Tuohy Connection, CODE: INTVM-CC. For use in Orthopedic / spinal procedures.Class IIMar 25, 2021Products distributed as sterile may not have been adequately |
| ZVplasty, Direct Bipedicular, Bone Access Kit with Coxaial Cannula, REF VCF-DDSKbd. For use in Orthopedic / spinal procClass IIMar 25, 2021Products distributed as sterile may not have been adequately |
| 10G BEVELED TROCAR/CANNULA. For use in Orthopedic / spinal procedures.Class IIMar 25, 2021Products distributed as sterile may not have been adequately |
| ZVplasty Cement Delivery Cannula, REF VCF-1007. For use in Orthopedic / spinal procedures.Class IIMar 25, 2021Products distributed as sterile may not have been adequately |
| ZVplasty Biopsy Device, 11 Gauge, REF VCF-1010-11. For use in Orthopedic / spinal procedures.Class IIMar 25, 2021Products distributed as sterile may not have been adequately |