Zavation Recalls
71 recalls on record · June 9, 2021 to June 9, 2021 · Medical Devices
June 9, 2021Medical DevicesFDA
Zavation recalls VERTEBREX SINGLE BALLOON KIT, REF VBRX-20-SBK-10. For use in Orthopedic / spinal procedures.
Hazard: Products distributed as sterile may not have been adequately sterilized
June 9, 2021Medical DevicesFDA
Zavation recalls VERTEBREX SINGLE BALLOON KIT, REF VBRX-15-SBK-10. For use in Orthopedic / spinal procedures.
Hazard: Products distributed as sterile may not have been adequately sterilized
June 9, 2021Medical DevicesFDA
Zavation recalls OsteoFlex Cement and Mixing System, REF VCF-OSFL. For use in Orthopedic / spinal procedures.
Hazard: Products distributed as sterile may not have been adequately sterilized
June 9, 2021Medical DevicesFDA
Zavation recalls ZVPlasty, 11G, 15mm Traditional Bipedicular Kit, REF VCF-1115-2. For use in Orthopedic / spinal procedures.
Hazard: Products distributed as sterile may not have been adequately sterilized
June 9, 2021Medical DevicesFDA
Zavation recalls ZVplasty System, 20mm, Part# VCF-1020-2. For use in Orthopedic / spinal procedures.
Hazard: Products distributed as sterile may not have been adequately sterilized
June 9, 2021Medical DevicesFDA
Zavation recalls ZVplasty 10G, 20mm, Traditional Unipedicular Kit, REF VCF-1020-1. For use in Orthopedic / spinal procedures.
Hazard: Products distributed as sterile may not have been adequately sterilized
June 9, 2021Medical DevicesFDA
Zavation recalls ZVplasty 10G, 15mm Single Balloon Kit, REF VCF-SBK. For use in Orthopedic / spinal procedures.
Hazard: Products distributed as sterile may not have been adequately sterilized
June 9, 2021Medical DevicesFDA
Zavation recalls ZVplasty 10G, FLEX KYPHOPLASTY, REF VCF-1015-FLEX. For use in Orthopedic / spinal procedures.
Hazard: Products distributed as sterile may not have been adequately sterilized
June 9, 2021Medical DevicesFDA
Zavation recalls ZVplasty System, 15mm, Part Numbers: a) VCF-1015-2 b) VCF-1015-2A. For use in Orthopedic / spinal procedures.
Hazard: Products distributed as sterile may not have been adequately sterilized
June 9, 2021Medical DevicesFDA
Zavation recalls ZVplasty 10G, 15mm, Additional Level Kit, REF VCF-1015-1A. For use in Orthopedic / spinal procedures.
Hazard: Products distributed as sterile may not have been adequately sterilized
June 9, 2021Medical DevicesFDA
Zavation recalls ZVplasty System, 15mm, Part# VCF-1015-1. For use in Orthopedic / spinal procedures.
Hazard: Products distributed as sterile may not have been adequately sterilized
June 9, 2021Medical DevicesFDA
Zavation recalls ZVplasty System, 15mm, Part# VCF-1015-1. For use in Orthopedic / spinal procedures.
Hazard: Products distributed as sterile may not have been adequately sterilized
June 9, 2021Medical DevicesFDA
Zavation recalls ZVplasty, 10G, 10mm Double Balloon Kit, REF VCF-1010-DBK. For use in Orthopedic / spinal procedures.
Hazard: Products distributed as sterile may not have been adequately sterilized
June 9, 2021Medical DevicesFDA
Zavation recalls ZVplasty System, 10mm, Pat# VCF-1010-2. For use in Orthopedic / spinal procedures.
Hazard: Products distributed as sterile may not have been adequately sterilized
June 9, 2021Medical DevicesFDA
Zavation recalls OsteoFlex BONE CEMENT, REF Numbers: a) INTV-OSFL b) INTV-OSFL-LV. For use in Orthopedic / spinal procedures.
Hazard: Products distributed as sterile may not have been adequately sterilized
June 9, 2021Medical DevicesFDA
Zavation recalls InterV 11G Kyphoplasty Kit, REF Numbers: a) INTVMN-10-DSK b) INTVMN-15-DSK c) INTVMN-15-DSKC d) INTVMN-20-DSK. F
Hazard: Products distributed as sterile may not have been adequately sterilized
June 9, 2021Medical DevicesFDA
Zavation recalls InterV 10G Bone Access Tools/Kit, REF INTVM-FLNK. For use in Orthopedic / spinal procedures.
Hazard: Products distributed as sterile may not have been adequately sterilized
June 9, 2021Medical DevicesFDA
Zavation recalls InterV CurvePlus Kit, REF Numbers: a) INTVMC-15-FLDSK b) INTVMC-20-FLDSK. For use in Orthopedic / spinal procedures.
Hazard: Products distributed as sterile may not have been adequately sterilized
June 9, 2021Medical DevicesFDA
Zavation recalls InterV, 10G FLEX Kyphoplasty, REF Number: a) INTVM-15-FLDSK b) INTVM-20-FLDSK. For use in Orthopedic / spinal proce
Hazard: Products distributed as sterile may not have been adequately sterilized
June 9, 2021Medical DevicesFDA
Zavation recalls InterV, 10G Kyphoplasty Kits, REF numbers: a) INTVM-10-DSK b) INTVM-10-SBK c) INTVM-15-DSK d) INTVM-15-DSKC e) INTV
Hazard: Products distributed as sterile may not have been adequately sterilized
June 9, 2021Medical DevicesFDA
Zavation recalls CEMIX - CEMENT MIXING SYSTEM STERILE, CODE INTV-MMS. For use in Orthopedic / spinal procedures.
Hazard: Products distributed as sterile may not have been adequately sterilized
June 9, 2021Medical DevicesFDA
Zavation recalls 10 GAUGE DIRECT UNILATERAL STYLET (1 X DIAMOND 1 X BEVEL) STERILE. For use in Orthopedic / spinal procedures.
Hazard: Products distributed as sterile may not have been adequately sterilized
June 9, 2021Medical DevicesFDA
Zavation recalls 10G BEVELED TROCAR/CANNULA. For use in Orthopedic / spinal procedures.
Hazard: Products distributed as sterile may not have been adequately sterilized
June 9, 2021Medical DevicesFDA
Zavation recalls 10G CEMENT DELIVERY CANNULA. For use in Orthopedic / spinal procedures.
Hazard: Products distributed as sterile may not have been adequately sterilized
June 9, 2021Medical DevicesFDA
Zavation recalls 10 GAUGE DRILL STERILE. For use in Orthopedic / spinal procedures.
Hazard: Products distributed as sterile may not have been adequately sterilized
June 9, 2021Medical DevicesFDA
Zavation recalls 10G COAXIAL CANNULA WITH TUOHY CONNECTION STERILE. For use in Orthopedic / spinal procedures.
Hazard: Products distributed as sterile may not have been adequately sterilized
June 9, 2021Medical DevicesFDA
Zavation recalls 10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES STERILE. For use in Orthopedic / spinal procedures.
Hazard: Products distributed as sterile may not have been adequately sterilized
June 9, 2021Medical DevicesFDA
Zavation recalls 10G DIRECT SINGLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.
Hazard: Products distributed as sterile may not have been adequately sterilized
June 9, 2021Medical DevicesFDA
Zavation recalls 10G DIRECT DOUBLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.
Hazard: Products distributed as sterile may not have been adequately sterilized
June 9, 2021Medical DevicesFDA
Zavation recalls 10G DOUBLE CEMENT DELIVERY KIT (8 FILLERS). For use in Orthopedic / spinal procedures.
Hazard: Products distributed as sterile may not have been adequately sterilized