Zavation: 71 FDA recall reports
Every medical device recall the FDA has published for Zavation. The fault, and how the agency graded it.
71Reports
0Class I
0Ongoing
2021-06-09Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
10G DIRECT DOUBLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.
Z-1738-2021 · Class II · reported 2021-06-09 · Terminated
- Why it was recalled
- Products distributed as sterile may not have been adequately sterilized
- Product
- 10G DIRECT DOUBLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.
- Where it went
- US nationwide distribution.
ZVplasty System, 15mm, Part# VCF-1015-1. For use in Orthopedic / spinal procedures.
Z-1760-2021 · Class II · reported 2021-06-09 · Terminated
- Why it was recalled
- Products distributed as sterile may not have been adequately sterilized
- Product
- ZVplasty System, 15mm, Part# VCF-1015-1. For use in Orthopedic / spinal procedures.
- Where it went
- US nationwide distribution.
ZVplasty Unipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCF-SCDK. For use in Orthopedic / spinal pro
Z-1721-2021 · Class II · reported 2021-06-09 · Terminated
- Why it was recalled
- Products distributed as sterile may not have been adequately sterilized
- Product
- ZVplasty Unipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCF-SCDK. For use in Orthopedic / spinal procedures.
- Where it went
- US nationwide distribution.
- How much
- 72 units
10G SINGLE CEMENT DELIVERY KIT (5 FILLERS). For use in Orthopedic / spinal procedures.
Z-1740-2021 · Class II · reported 2021-06-09 · Terminated
- Why it was recalled
- Products distributed as sterile may not have been adequately sterilized
- Product
- 10G SINGLE CEMENT DELIVERY KIT (5 FILLERS). For use in Orthopedic / spinal procedures.
- Where it went
- US nationwide distribution.
ZVplasty System, 10mm, Pat# VCF-1010-2. For use in Orthopedic / spinal procedures.
Z-1757-2021 · Class II · reported 2021-06-09 · Terminated
- Why it was recalled
- Products distributed as sterile may not have been adequately sterilized
- Product
- ZVplasty System, 10mm, Pat# VCF-1010-2. For use in Orthopedic / spinal procedures.
- Where it went
- US nationwide distribution.
- How much
- 31 units
ZVplasty Directional Cement Cannula (4 pieces per pack), REF VCF-1080-S4. For use in Orthopedic / spinal proc
Z-1726-2021 · Class II · reported 2021-06-09 · Terminated
- Why it was recalled
- Products distributed as sterile may not have been adequately sterilized
- Product
- ZVplasty Directional Cement Cannula (4 pieces per pack), REF VCF-1080-S4. For use in Orthopedic / spinal procedures.
- Where it went
- US nationwide distribution.
- How much
- 11 units
ZVplasty System, 15mm, Part# VCF-1015-1. For use in Orthopedic / spinal procedures.
Z-1759-2021 · Class II · reported 2021-06-09 · Terminated
- Why it was recalled
- Products distributed as sterile may not have been adequately sterilized
- Product
- ZVplasty System, 15mm, Part# VCF-1015-1. For use in Orthopedic / spinal procedures.
- Where it went
- US nationwide distribution.
- How much
- 516 units
11G DIRECT SINGLE - DELIVERY (4 FILLERS-4 SYRINGES) CODE: INTVMN-SCDK. For use in Orthopedic / spinal proce
Z-1717-2021 · Class II · reported 2021-06-09 · Terminated
- Why it was recalled
- Products distributed as sterile may not have been adequately sterilized
- Product
- 11G DIRECT SINGLE - DELIVERY (4 FILLERS-4 SYRINGES) CODE: INTVMN-SCDK. For use in Orthopedic / spinal procedures.
- Where it went
- US nationwide distribution.
- How much
- 7 units
10 Gauge Drill, CODE: INTVM-DRL. For use in Orthopedic / spinal procedures.
Z-1731-2021 · Class II · reported 2021-06-09 · Terminated
- Why it was recalled
- Products distributed as sterile may not have been adequately sterilized
- Product
- 10 Gauge Drill, CODE: INTVM-DRL. For use in Orthopedic / spinal procedures.
- Where it went
- US nationwide distribution.
- How much
- 58 units
10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES, CODE: INTVM-SCDK. For use in Orthopedic / spinal proced
Z-1720-2021 · Class II · reported 2021-06-09 · Terminated
- Why it was recalled
- Products distributed as sterile may not have been adequately sterilized
- Product
- 10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES, CODE: INTVM-SCDK. For use in Orthopedic / spinal procedures.
- Where it went
- US nationwide distribution.
- How much
- 122 units
ZVplasty System, 15mm, Part Numbers: a) VCF-1015-2 b) VCF-1015-2A. For use in Orthopedic / spinal proced
Z-1762-2021 · Class II · reported 2021-06-09 · Terminated
- Why it was recalled
- Products distributed as sterile may not have been adequately sterilized
- Product
- ZVplasty System, 15mm, Part Numbers: a) VCF-1015-2 b) VCF-1015-2A. For use in Orthopedic / spinal procedures.
- Where it went
- US nationwide distribution.
- How much
- 195 units
11G DIAMOND TROCAR/CANNULA. For use in Orthopedic / spinal procedures.
Z-1737-2021 · Class II · reported 2021-06-09 · Terminated
- Why it was recalled
- Products distributed as sterile may not have been adequately sterilized
- Product
- 11G DIAMOND TROCAR/CANNULA. For use in Orthopedic / spinal procedures.
- Where it went
- US nationwide distribution.
ZVplasty Direct Bipedicular Bone Access Kit with Drill, 10 Gauge, VCF-DDBAK. For use in Orthopedic / spinal p
Z-1706-2021 · Class II · reported 2021-06-09 · Terminated
- Why it was recalled
- Products distributed as sterile may not have been adequately sterilized
- Product
- ZVplasty Direct Bipedicular Bone Access Kit with Drill, 10 Gauge, VCF-DDBAK. For use in Orthopedic / spinal procedures.
- Where it went
- US nationwide distribution.
10G DOUBLE CEMENT DELIVERY KIT (8 FILLERS). For use in Orthopedic / spinal procedures.
Z-1741-2021 · Class II · reported 2021-06-09 · Terminated
- Why it was recalled
- Products distributed as sterile may not have been adequately sterilized
- Product
- 10G DOUBLE CEMENT DELIVERY KIT (8 FILLERS). For use in Orthopedic / spinal procedures.
- Where it went
- US nationwide distribution.
10G CEMENT DELIVERY CANNULA. For use in Orthopedic / spinal procedures.
Z-1747-2021 · Class II · reported 2021-06-09 · Terminated
- Why it was recalled
- Products distributed as sterile may not have been adequately sterilized
- Product
- 10G CEMENT DELIVERY CANNULA. For use in Orthopedic / spinal procedures.
- Where it went
- US nationwide distribution.
ZVplasty Bipedicular Cement Delivery Cannula, 11 Gauge, REF VCF-DCDK-11. For use in Orthopedic / spinal proce
Z-1710-2021 · Class II · reported 2021-06-09 · Terminated
- Why it was recalled
- Products distributed as sterile may not have been adequately sterilized
- Product
- ZVplasty Bipedicular Cement Delivery Cannula, 11 Gauge, REF VCF-DCDK-11. For use in Orthopedic / spinal procedures.
- Where it went
- US nationwide distribution.
- How much
- 1 unit
InterV, 10G FLEX Kyphoplasty, REF Number: a) INTVM-15-FLDSK b) INTVM-20-FLDSK. For use in Orthopedic / sp
Z-1752-2021 · Class II · reported 2021-06-09 · Terminated
- Why it was recalled
- Products distributed as sterile may not have been adequately sterilized
- Product
- InterV, 10G FLEX Kyphoplasty, REF Number: a) INTVM-15-FLDSK b) INTVM-20-FLDSK. For use in Orthopedic / spinal procedures.
- Where it went
- US nationwide distribution.
- How much
- 178 units
ZVplasty, 10G, 10mm Double Balloon Kit, REF VCF-1010-DBK. For use in Orthopedic / spinal procedures.
Z-1758-2021 · Class II · reported 2021-06-09 · Terminated
- Why it was recalled
- Products distributed as sterile may not have been adequately sterilized
- Product
- ZVplasty, 10G, 10mm Double Balloon Kit, REF VCF-1010-DBK. For use in Orthopedic / spinal procedures.
- Where it went
- US nationwide distribution.
- How much
- 7 units
InterV CurvePlus Kit, REF Numbers: a) INTVMC-15-FLDSK b) INTVMC-20-FLDSK. For use in Orthopedic / spinal p
Z-1753-2021 · Class II · reported 2021-06-09 · Terminated
- Why it was recalled
- Products distributed as sterile may not have been adequately sterilized
- Product
- InterV CurvePlus Kit, REF Numbers: a) INTVMC-15-FLDSK b) INTVMC-20-FLDSK. For use in Orthopedic / spinal procedures.
- Where it went
- US nationwide distribution.
- How much
- 36 units
11G BEVELED TROCAR/CANNULA. For use in Orthopedic / spinal procedures.
Z-1736-2021 · Class II · reported 2021-06-09 · Terminated
- Why it was recalled
- Products distributed as sterile may not have been adequately sterilized
- Product
- 11G BEVELED TROCAR/CANNULA. For use in Orthopedic / spinal procedures.
- Where it went
- US nationwide distribution.
ZVplasty Direct Access Beveled Tip Trocar, 10 Gauge, REF VCF-1022. For use in Orthopedic / spinal procedures.
Z-1703-2021 · Class II · reported 2021-06-09 · Terminated
- Why it was recalled
- Products distributed as sterile may not have been adequately sterilized
- Product
- ZVplasty Direct Access Beveled Tip Trocar, 10 Gauge, REF VCF-1022. For use in Orthopedic / spinal procedures.
- Where it went
- US nationwide distribution.
- How much
- 335 units
ZVplasty Drill, 10 Gauge, REF VCF-1006. For use in Orthopedic / spinal procedures.
Z-1702-2021 · Class II · reported 2021-06-09 · Terminated
- Why it was recalled
- Products distributed as sterile may not have been adequately sterilized
- Product
- ZVplasty Drill, 10 Gauge, REF VCF-1006. For use in Orthopedic / spinal procedures.
- Where it went
- US nationwide distribution.
- How much
- 38 units
ZVplasty Direct Access Diamond Tip Trocar, 11 Gauge, REF VCF-1023-11. For use in Orthopedic / spinal procedur
Z-1712-2021 · Class II · reported 2021-06-09 · Terminated
- Why it was recalled
- Products distributed as sterile may not have been adequately sterilized
- Product
- ZVplasty Direct Access Diamond Tip Trocar, 11 Gauge, REF VCF-1023-11. For use in Orthopedic / spinal procedures.
- Where it went
- US nationwide distribution.
- How much
- 113 units
VERTEBREX SINGLE BALLOON KIT, REF VBRX-15-SBK-10. For use in Orthopedic / spinal procedures.
Z-1769-2021 · Class II · reported 2021-06-09 · Terminated
- Why it was recalled
- Products distributed as sterile may not have been adequately sterilized
- Product
- VERTEBREX SINGLE BALLOON KIT, REF VBRX-15-SBK-10. For use in Orthopedic / spinal procedures.
- Where it went
- US nationwide distribution.
- How much
- 140 units
10G DIRECT DOUBLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.
Z-1742-2021 · Class II · reported 2021-06-09 · Terminated
- Why it was recalled
- Products distributed as sterile may not have been adequately sterilized
- Product
- 10G DIRECT DOUBLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.
- Where it went
- US nationwide distribution.
10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES STERILE. For use in Orthopedic / spinal procedures.
Z-1744-2021 · Class II · reported 2021-06-09 · Terminated
- Why it was recalled
- Products distributed as sterile may not have been adequately sterilized
- Product
- 10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES STERILE. For use in Orthopedic / spinal procedures.
- Where it went
- US nationwide distribution.
10G DIRECT SINGLE - ACCESS, CODE: INTV-DWCb. For use in Orthopedic / spinal procedures.
Z-1727-2021 · Class II · reported 2021-06-09 · Terminated
- Why it was recalled
- Products distributed as sterile may not have been adequately sterilized
- Product
- 10G DIRECT SINGLE - ACCESS, CODE: INTV-DWCb. For use in Orthopedic / spinal procedures.
- Where it went
- US nationwide distribution.
- How much
- 24 units
InterV 11G Kyphoplasty Kit, REF Numbers: a) INTVMN-10-DSK b) INTVMN-15-DSK c) INTVMN-15-DSKC d) INTVMN-
Z-1755-2021 · Class II · reported 2021-06-09 · Terminated
- Why it was recalled
- Products distributed as sterile may not have been adequately sterilized
- Product
- 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 Orthopedic / spinal procedures.
- Where it went
- US nationwide distribution.
- How much
- 119 units
ZVplasty Direct Access Bevel Tip Trocar, 11 Gauge, REF VCF-1022-11. For use in Orthopedic / spinal procedures
Z-1711-2021 · Class II · reported 2021-06-09 · Terminated
- Why it was recalled
- Products distributed as sterile may not have been adequately sterilized
- Product
- ZVplasty Direct Access Bevel Tip Trocar, 11 Gauge, REF VCF-1022-11. For use in Orthopedic / spinal procedures.
- Where it went
- US nationwide distribution.
- How much
- 98 units
11G DIRECT WORKING CANNULA DIAMOND TIP MINI, CODE: INTVMN-DWCD. For use in Orthopedic / spinal procedures.
Z-1719-2021 · Class II · reported 2021-06-09 · Terminated
- Why it was recalled
- Products distributed as sterile may not have been adequately sterilized
- Product
- 11G DIRECT WORKING CANNULA DIAMOND TIP MINI, CODE: INTVMN-DWCD. For use in Orthopedic / spinal procedures.
- Where it went
- US nationwide distribution.
- How much
- 58 units
Showing the 30 most recent of 71. The rest are searchable at the FDA enforcement report database.
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
← All device recalls