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-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-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-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-1700-2021·2021-06-09

    Zavation Spinal Stylet Instruments 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. Patients who received this device should contact their healthcare provider.

    Product
    10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), INTVM-DSSKBD. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1767-2021·2021-06-09

    ZVPlasty Orthopedic Spinal Device Recalled for Inadequate Sterilization

    Zavation is recalling ZVPlasty spinal orthopedic devices that may not have been properly sterilized, creating a risk of infection. The recall affects 49 units distributed nationwide.

    Product
    ZVPlasty, 11G, 15mm Traditional Bipedicular Kit, REF VCF-1115-2. 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-1708-2021·2021-06-09

    ZVplasty Bone Access Kit Recalled for Inadequate Sterilization

    Zavation has recalled the ZVplasty Direct Unipedicular Bone Access Kit with Drill due to potential sterilization failure. The surgical device is used in orthopedic and spinal procedures, with 11 units distributed nationwide.

    Product
    ZVplasty Direct Unipedicular Bone Access Kit with Drill, 10 Gauge, REF VCF-DSBAK. 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-1706-2021·2021-06-09

    ZVplasty Spinal Bone Access Kit Recall Due to Inadequate Sterilization

    Zavation is recalling ZVplasty Direct Bipedicular Bone Access Kits due to inadequate sterilization. Products distributed as sterile nationwide may pose infection risk if used in spinal procedures.

    Product
    ZVplasty Direct Bipedicular Bone Access Kit with Drill, 10 Gauge, VCF-DDBAK. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1724-2021·2021-06-09

    Zavation Surgical Trocars Recalled Due to Sterilization Concerns

    Zavation recalled 98 surgical trocars that may not be adequately sterilized. Products were distributed as sterile but may pose infection risks from inadequate sterilization.

    Product
    ZVplasty Direct Access Bevel Tip Trocar, 11 Gauge, REF VCF-1022-11. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1749-2021·2021-06-09

    Zavation Orthopedic Spinal Stylets Recalled for Inadequate Sterilization

    Zavation has recalled 10 gauge direct unilateral sterile stylets used in orthopedic and spinal procedures due to inadequate sterilization. Products distributed as sterile may not meet sterilization standards.

    Product
    10 GAUGE DIRECT UNILATERAL STYLET (1 X DIAMOND 1 X BEVEL) STERILE. 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-1744-2021·2021-06-09

    Zavation Orthopedic Cement Delivery System Recalled for Sterilization Failure

    Zavation recalled its 10-gauge orthopedic cement delivery system because products distributed as sterile may not have been adequately sterilized. Healthcare providers and patients with concerns should contact Zavation.

    Product
    10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES STERILE. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1727-2021·2021-06-09

    Orthopedic spinal surgical device recalled for inadequate sterilization

    Zavation recalls orthopedic spinal devices distributed as sterile but potentially inadequately sterilized. Patients who received these devices should consult their healthcare provider.

    Product
    10G DIRECT SINGLE - ACCESS, CODE: INTV-DWCb. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1722-2021·2021-06-09

    ZVplasty Biopsy Device Lot 20061369 Recalled for Inadequate Sterilization

    Zavation is recalling 162 units of the ZVplasty Biopsy Device (Lot 20061369) used in orthopedic and spinal procedures because they may not have been adequately sterilized.

    Product
    ZVplasty Biopsy Device, 10 Gauge, REF VCF-1010. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1747-2021·2021-06-09

    Zavation 10G Cement Delivery Cannula Recalled for Inadequate Sterilization

    Zavation is recalling its 10G Cement Delivery Cannula used in orthopedic and spinal procedures nationwide due to products distributed as sterile not being adequately sterilized.

    Product
    10G CEMENT DELIVERY CANNULA. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1737-2021·2021-06-09

    Orthopedic Trocar and Cannula Recalled for Sterilization Failure

    Zavation's 11G Diamond Trocar/Cannula, used in orthopedic and spinal procedures, may not have been adequately sterilized. The manufacturer is recalling affected units distributed nationwide.

    Product
    11G DIAMOND TROCAR/CANNULA. 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-1735-2021·2021-06-09

    Orthopedic Cement Delivery Kits Recalled Due to Sterilization Concerns

    Zavation's 10G cement delivery kits for spinal procedures may not be adequately sterilized despite being marketed as sterile. Patients and healthcare providers should contact Zavation regarding potentially affected units.

    Product
    10G SINGLE CEMENT DELIVERY KIT (5 FILLERS). For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1739-2021·2021-06-09

    11G Direct Double Bone Access Kit May Not Be Adequately Sterilized

    Zavation's 11G Direct Double Bone Access Kit for spinal and orthopedic procedures may not have been adequately sterilized during manufacturing. Distributed nationwide, the non-sterile devices may pose infection risks to patients.

    Product
    11G DIRECT DOUBLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1709-2021·2021-06-09

    ZVplasty Unipedicular Cement Delivery Cannula Kit May Not Be Adequately Sterilized

    Zavation recalls ZVplasty Unipedicular Cement Delivery Cannula Kit (72 units nationwide) due to sterilization failure. Products distributed as sterile may not have been adequately sterilized.

    Product
    ZVplasty Unipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCG-SCDK. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide