The Recall Desk

Manufacturer

Zavation

71 recalls in our database name Zavation as the manufacturing or recalling firm.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

51–71 of 71

  • HighFDA (Devices)·Z-1761-2021·2021-06-09

    Spinal surgery implant kit recalled for inadequate sterilization

    Zavation is recalling ZVplasty 10G spinal implant kits that may not have been properly sterilized. The affected devices were distributed nationwide and may pose infection risk if implanted.

    Product
    ZVplasty 10G, 15mm, Additional Level Kit, REF VCF-1015-1A. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1714-2021·2021-06-09

    Zavation Orthopedic Stylet Recalled for Inadequate Sterilization

    Zavation is recalling 56 units of 10 gauge direct unilateral stylets used in spinal procedures because products distributed as sterile may not have been adequately sterilized. Affected units were distributed nationwide.

    Product
    10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), CODE INTVM-DSSKbd. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1717-2021·2021-06-09

    Orthopedic spinal implants recalled due to inadequate sterilization

    Zavation is recalling 7 units of 11G DIRECT SINGLE spinal implants (lots 2001185 and 2001243) because products distributed as sterile may not have been adequately sterilized. The devices were distributed nationwide.

    Product
    11G DIRECT SINGLE - DELIVERY (4 FILLERS-4 SYRINGES) CODE: INTVMN-SCDK. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1743-2021·2021-06-09

    10G Direct Single Bone Access Kits recalled for sterilization failure

    Zavation's 10G Direct Single Bone Access Kits are being recalled because products distributed as sterile may not have been adequately sterilized, posing infection risk in orthopedic procedures.

    Product
    10G DIRECT SINGLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1712-2021·2021-06-09

    ZVplasty Direct Access Trocar Recalled for Inadequate Sterilization

    Zavation is recalling ZVplasty Direct Access Diamond Tip Trocars (11 Gauge) because some units may not be adequately sterilized. These surgical instruments are used in orthopedic and spinal procedures.

    Product
    ZVplasty Direct Access Diamond Tip Trocar, 11 Gauge, REF VCF-1023-11. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1753-2021·2021-06-09

    Orthopedic Spinal Surgery Kit Recalled for Inadequate Sterilization

    Zavation is recalling InterV CurvePlus surgical kits because products distributed as sterile may not have been adequately sterilized. 36 units were distributed nationwide.

    Product
    InterV CurvePlus Kit, REF Numbers: a) INTVMC-15-FLDSK b) INTVMC-20-FLDSK. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1763-2021·2021-06-09

    ZVplasty 10G FLEX Kyphoplasty Spinal Device Recall Due to Sterilization Failure

    Zavation is recalling 19 units of ZVplasty 10G FLEX KYPHOPLASTY spinal devices because distributed units may not have been adequately sterilized, posing infection risk to patients.

    Product
    ZVplasty 10G, FLEX KYPHOPLASTY, REF VCF-1015-FLEX. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1751-2021·2021-06-09

    Zavation InterV 10G kyphoplasty kits recalled due to inadequate sterilization

    Zavation is recalling InterV 10G Kyphoplasty Kits because products distributed as sterile may not have been adequately sterilized. The recall affects 503 units distributed nationwide.

    Product
    InterV, 10G Kyphoplasty Kits, REF numbers: a) INTVM-10-DSK b) INTVM-10-SBK c) INTVM-15-DSK d) INTVM-15-DSKC e) INTVM-15-SBK f) INTVM-15-SIKBC g) INTVM-20-DSK h) INTVM-20-SBK. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1718-2021·2021-06-09

    Spinal surgical cement delivery cannulas recalled for inadequate sterilization

    Zavation is recalling 130 units of 10-gauge cement delivery cannulas used in spinal procedures due to inadequate sterilization. These devices may not be sterile, creating infection risk for surgical patients.

    Product
    10 GAUGE CEMENT DELIVERY CANNULA, CODE: INTVM-CDC. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1719-2021·2021-06-09

    Zavation Direct Working Cannula Recalled for Sterilization Defect

    Zavation is recalling 58 units of 11G Direct Working Cannula Diamond Tip Mini devices (Lot 2002437) because they may not have been adequately sterilized before distribution.

    Product
    11G DIRECT WORKING CANNULA DIAMOND TIP MINI, CODE: INTVMN-DWCD. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1729-2021·2021-06-09

    Orthopedic Drill Kit Recalled for Potential Sterilization Failure

    Zavation is recalling the ZVplasty Direct Bipedicular Bone Access Kit due to products potentially lacking adequate sterilization. The 15 units affected (Lot 20071774, 19123262) were distributed nationwide.

    Product
    ZVplasty Direct Bipedicular Bone Access Kit with Drill, 11 Gauge, REF VCF-DDBAK-11. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1701-2021·2021-06-09

    Cement Delivery Cannula May Not Be Adequately Sterilized

    Zavation is recalling 10 gauge cement delivery cannulas (INTVM-CDC) used in orthopedic procedures because distributed products may not have been adequately sterilized. The recall affects 130 units distributed nationwide.

    Product
    10 GAUGE CEMENT DELIVERY CANNULA, INTVM-CDC. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1734-2021·2021-06-09

    Zavation 10G Direct Single Bone Access Kit Recall Due to Inadequate Sterilization

    Zavation is recalling its 10G Direct Single Bone Access Kit because some units distributed as sterile may not have been adequately sterilized. The kit is used in orthopedic and spinal procedures and was distributed nationwide.

    Product
    10G DIRECT SINGLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1742-2021·2021-06-09

    Orthopedic bone access kits recalled for inadequate sterilization

    Zavation recalled its 10G Direct Double Bone Access Kit because some units distributed as sterile may not have been adequately sterilized. Affected devices are used in orthopedic and spinal procedures.

    Product
    10G DIRECT DOUBLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1759-2021·2021-06-09

    ZVplasty Orthopedic Spinal System Units Recalled Due to Inadequate Sterilization

    Zavation is recalling 516 units of ZVplasty System (15mm) spinal surgical devices because products distributed as sterile may not have been adequately sterilized. Patients who received this device may face infection risk.

    Product
    ZVplasty System, 15mm, Part# VCF-1015-1. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1764-2021·2021-06-09

    Zavation Spinal Balloon Kit Recall Due to Inadequate Sterilization

    Zavation is recalling 79 units of the ZVplasty 10G, 15mm Single Balloon Kit due to inadequate sterilization. Affected devices may pose a contamination risk for patients undergoing spinal procedures.

    Product
    ZVplasty 10G, 15mm Single Balloon Kit, REF VCF-SBK. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1731-2021·2021-06-09

    10 Gauge Drill for Orthopedic Surgery Recalled for Sterilization Failure

    Zavation recalled 58 units of 10 Gauge Drill (Lot 20102486) used in orthopedic/spinal procedures due to potential inadequate sterilization. Patients should contact their surgeon if they received treatment with an affected device.

    Product
    10 Gauge Drill, CODE: INTVM-DRL. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1766-2021·2021-06-09

    ZVplasty orthopedic surgical devices may lack adequate sterilization

    Zavation is recalling 24 units of the ZVplasty System used in orthopedic and spinal procedures due to potential inadequate sterilization. Patients who received recalled devices should contact their healthcare provider.

    Product
    ZVplasty System, 20mm, Part# VCF-1020-2. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1733-2021·2021-06-09

    Zavation 10G Beveled Trocar/Cannula Recalled Due to Inadequate Sterilization

    Zavation is recalling 10G beveled trocar/cannula instruments used in orthopedic and spinal procedures due to potential inadequate sterilization, creating infection risk.

    Product
    10G BEVELED TROCAR/CANNULA. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1705-2021·2021-06-09

    ZVplasty Cement Delivery Cannulas Recalled for Inadequate Sterilization

    Zavation recalled 14 units of ZVplasty Bipedicular Cement Delivery Cannula Kits distributed nationwide because they may not have been adequately sterilized.

    Product
    ZVplasty, Bipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCF-DCDK. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1769-2021·2021-06-09

    Zavation Vertebrex Spinal Balloon Kit May Not Be Properly Sterilized

    Zavation has recalled 140 units of its Vertebrex Single Balloon Kit used in spinal procedures due to inadequate sterilization. Products marketed as sterile may not meet sterility standards.

    Product
    VERTEBREX SINGLE BALLOON KIT, REF VBRX-15-SBK-10. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide