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All Recalls

Every Zavation Recall

Sorted by most recent. Click any recall for full details.

46 recalls
High RiskFDA
Zavation
10G DIRECT DOUBLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.
Medical Devices·0 affected·Mar 25, 2021
High RiskFDA
Zavation
ZVplasty System, 15mm, Part# VCF-1015-1. For use in Orthopedic / spinal procedures.
Medical Devices·0 affected·Mar 25, 2021
High RiskFDA
Zavation
ZVplasty Unipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCF-SCDK. For use in Orthopedic / spinal procedures.
Medical Devices·72 affected·Mar 25, 2021
High RiskFDA
Zavation
10G SINGLE CEMENT DELIVERY KIT (5 FILLERS). For use in Orthopedic / spinal procedures.
Medical Devices·0 affected·Mar 25, 2021
High RiskFDA
Zavation
ZVplasty System, 10mm, Pat# VCF-1010-2. For use in Orthopedic / spinal procedures.
Medical Devices·31 affected·Mar 25, 2021
High RiskFDA
Zavation
ZVplasty Directional Cement Cannula (4 pieces per pack), REF VCF-1080-S4. For use in Orthopedic / spinal procedures.
Medical Devices·11 affected·Mar 25, 2021
High RiskFDA
Zavation
ZVplasty System, 15mm, Part# VCF-1015-1. For use in Orthopedic / spinal procedures.
Medical Devices·516 affected·Mar 25, 2021
High RiskFDA
Zavation
11G DIRECT SINGLE - DELIVERY (4 FILLERS-4 SYRINGES) CODE: INTVMN-SCDK. For use in Orthopedic / spinal procedures.
Medical Devices·7 affected·Mar 25, 2021
High RiskFDA
Zavation
10 Gauge Drill, CODE: INTVM-DRL. For use in Orthopedic / spinal procedures.
Medical Devices·58 affected·Mar 25, 2021
High RiskFDA
Zavation
10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES, CODE: INTVM-SCDK. For use in Orthopedic / spinal procedures.
Medical Devices·122 affected·Mar 25, 2021
High RiskFDA
Zavation
ZVplasty System, 15mm, Part Numbers: a) VCF-1015-2 b) VCF-1015-2A. For use in Orthopedic / spinal procedures.
Medical Devices·195 affected·Mar 25, 2021
High RiskFDA
Zavation
11G DIAMOND TROCAR/CANNULA. For use in Orthopedic / spinal procedures.
Medical Devices·0 affected·Mar 25, 2021
High RiskFDA
Zavation
ZVplasty Direct Bipedicular Bone Access Kit with Drill, 10 Gauge, VCF-DDBAK. For use in Orthopedic / spinal procedures.
Medical Devices·0 affected·Mar 25, 2021
High RiskFDA
Zavation
10G DOUBLE CEMENT DELIVERY KIT (8 FILLERS). For use in Orthopedic / spinal procedures.
Medical Devices·0 affected·Mar 25, 2021
High RiskFDA
Zavation
10G CEMENT DELIVERY CANNULA. For use in Orthopedic / spinal procedures.
Medical Devices·0 affected·Mar 25, 2021
High RiskFDA
Zavation
ZVplasty Bipedicular Cement Delivery Cannula, 11 Gauge, REF VCF-DCDK-11. For use in Orthopedic / spinal procedures.
Medical Devices·1 affected·Mar 25, 2021
High RiskFDA
Zavation
InterV, 10G FLEX Kyphoplasty, REF Number: a) INTVM-15-FLDSK b) INTVM-20-FLDSK. For use in Orthopedic / spinal procedures.
Medical Devices·178 affected·Mar 25, 2021
High RiskFDA
Zavation
ZVplasty, 10G, 10mm Double Balloon Kit, REF VCF-1010-DBK. For use in Orthopedic / spinal procedures.
Medical Devices·7 affected·Mar 25, 2021
High RiskFDA
Zavation
InterV CurvePlus Kit, REF Numbers: a) INTVMC-15-FLDSK b) INTVMC-20-FLDSK. For use in Orthopedic / spinal procedures.
Medical Devices·36 affected·Mar 25, 2021
High RiskFDA
Zavation
11G BEVELED TROCAR/CANNULA. For use in Orthopedic / spinal procedures.
Medical Devices·0 affected·Mar 25, 2021
High RiskFDA
Zavation
ZVplasty Direct Access Beveled Tip Trocar, 10 Gauge, REF VCF-1022. For use in Orthopedic / spinal procedures.
Medical Devices·335 affected·Mar 25, 2021
High RiskFDA
Zavation
ZVplasty Drill, 10 Gauge, REF VCF-1006. For use in Orthopedic / spinal procedures.
Medical Devices·38 affected·Mar 25, 2021
High RiskFDA
Zavation
ZVplasty Direct Access Diamond Tip Trocar, 11 Gauge, REF VCF-1023-11. For use in Orthopedic / spinal procedures.
Medical Devices·113 affected·Mar 25, 2021
High RiskFDA
Zavation
VERTEBREX SINGLE BALLOON KIT, REF VBRX-15-SBK-10. For use in Orthopedic / spinal procedures.
Medical Devices·140 affected·Mar 25, 2021
High RiskFDA
Zavation
10G DIRECT DOUBLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.
Medical Devices·0 affected·Mar 25, 2021
High RiskFDA
Zavation
10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES STERILE. For use in Orthopedic / spinal procedures.
Medical Devices·0 affected·Mar 25, 2021
High RiskFDA
Zavation
10G DIRECT SINGLE - ACCESS, CODE: INTV-DWCb. For use in Orthopedic / spinal procedures.
Medical Devices·24 affected·Mar 25, 2021
High RiskFDA
Zavation
InterV 11G Kyphoplasty Kit, REF Numbers: a) INTVMN-10-DSK b) INTVMN-15-DSK c) INTVMN-15-DSKC d) INTVMN-20-DSK. For use in Orthope...
Medical Devices·119 affected·Mar 25, 2021
High RiskFDA
Zavation
ZVplasty Direct Access Bevel Tip Trocar, 11 Gauge, REF VCF-1022-11. For use in Orthopedic / spinal procedures.
Medical Devices·98 affected·Mar 25, 2021
High RiskFDA
Zavation
11G DIRECT WORKING CANNULA DIAMOND TIP MINI, CODE: INTVMN-DWCD. For use in Orthopedic / spinal procedures.
Medical Devices·58 affected·Mar 25, 2021
High RiskFDA
Zavation
10 GAUGE CEMENT DELIVERY CANNULA, CODE: INTVM-CDC. For use in Orthopedic / spinal procedures.
Medical Devices·130 affected·Mar 25, 2021
High RiskFDA
Zavation
ZVplasty Directional Cement Cannula Long, REF VCF-1080-L. For use in Orthopedic / spinal procedures.
Medical Devices·27 affected·Mar 25, 2021
High RiskFDA
Zavation
10 GAUGE DRILL STERILE. For use in Orthopedic / spinal procedures.
Medical Devices·0 affected·Mar 25, 2021
High RiskFDA
Zavation
10G BEVELED TROCAR/CANNULA. For use in Orthopedic / spinal procedures.
Medical Devices·0 affected·Mar 25, 2021
High RiskFDA
Zavation
ZVplasty Direct Bipedicular Bone Access Kit with Drill, 11 Gauge, REF VCF-DDBAK-11. For use in Orthopedic / spinal procedures.
Medical Devices·15 affected·Mar 25, 2021
High RiskFDA
Zavation
10G SINGLE CEMENT DELIVERY KIT (5 FILLERS). For use in Orthopedic / spinal procedures.
Medical Devices·0 affected·Mar 25, 2021
High RiskFDA
Zavation
10G DIRECT SINGLE - ACCESS, CODE INTVM-DSBAK. For use in Orthopedic / spinal procedures.
Medical Devices·2 affected·Mar 25, 2021
High RiskFDA
Zavation
ZVplasty Biopsy Device, 10 Gauge, REF VCF-1010. For use in Orthopedic / spinal procedures.
Medical Devices·162 affected·Mar 25, 2021
High RiskFDA
Zavation
ZVplasty 10G, FLEX KYPHOPLASTY, REF VCF-1015-FLEX. For use in Orthopedic / spinal procedures.
Medical Devices·19 affected·Mar 25, 2021
High RiskFDA
Zavation
10 GAUGE CEMENT DELIVERY CANNULA, INTVM-CDC. For use in Orthopedic / spinal procedures.
Medical Devices·130 affected·Mar 25, 2021
High RiskFDA
Zavation
ZVplasty Unipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCG-SCDK. For use in Orthopedic / spinal procedures.
Medical Devices·72 affected·Mar 25, 2021
High RiskFDA
Zavation
10G DIRECT SINGLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.
Medical Devices·0 affected·Mar 25, 2021
High RiskFDA
Zavation
ZVplasty, Bipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCF-DCDK. For use in Orthopedic / spinal procedures.
Medical Devices·14 affected·Mar 25, 2021
High RiskFDA
Zavation
ZVplasty 10G, 15mm, Additional Level Kit, REF VCF-1015-1A. For use in Orthopedic / spinal procedures.
Medical Devices·3 affected·Mar 25, 2021
High RiskFDA
Zavation
10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), INTVM-DSSKBD. For use in Orthopedic / spinal procedures.
Medical Devices·56 affected·Mar 25, 2021
High RiskFDA
Zavation
ZVplasty Direct Access Diamond Tip Trocar, 11 Gauge, REF VCF-1023-11. For use in Orthopedic / spinal procedures.
Medical Devices·113 affected·Mar 25, 2021