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.

1–25 of 71

HighFDA (Devices)·Z-1730-2021·2021-06-09
Zavation Coaxial Cannula Lot 20102495 Recalled for Inadequate Sterilization
Zavation's 10G Coaxial Cannula with Tuohy Connection (Lot 20102495) used in spinal and orthopedic procedures has been recalled due to inadequate sterilization. Patients should contact their healthcare provider if they received this product.
Product
10 G Coxaxial Cannula with Tuohy Connection, CODE: INTVM-CC. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1721-2021·2021-06-09
Spinal Surgery Cement Delivery Cannula Kits Recalled for Potential Sterilization Failure
Zavation is recalling ZVplasty Unipedicular Cement Delivery Cannula Kits distributed nationwide due to potential inadequate sterilization of sterile surgical devices.
Product
ZVplasty Unipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCF-SCDK. 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-1746-2021·2021-06-09
Zavation 10 Gauge Sterile Surgical Drill Recalled for Inadequate Sterilization
Zavation is recalling 10 gauge sterile surgical drills used in orthopedic and spinal procedures because products distributed as sterile may not have been adequately sterilized. Products were distributed nationwide.
Product
10 GAUGE DRILL STERILE. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1738-2021·2021-06-09
Zavation 10G Direct Double Bone Access Kit May Not Be Properly Sterilized
Zavation recalled its 10G Direct Double Bone Access Kit used in orthopedic surgery because products distributed as sterile may not have been adequately sterilized, potentially exposing patients to infection.
Product
10G DIRECT DOUBLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1710-2021·2021-06-09
FDA Recalls ZVplasty Cement Delivery Cannula Over Sterilization Failure
Zavation recalled ZVplasty Bipedicular Cement Delivery Cannulas (Lot 19123174) because products distributed as sterile may not have been adequately sterilized. These cannulas are used in spinal procedures; inadequate sterilization poses an infection risk.
Product
ZVplasty Bipedicular Cement Delivery Cannula, 11 Gauge, REF VCF-DCDK-11. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1720-2021·2021-06-09
Zavation spinal orthopedic cement delivery kits recalled for inadequate sterilization
Zavation is recalling 122 units of sterile orthopedic cement delivery kits that may not have been adequately sterilized. The kits were distributed nationwide for use in spinal and orthopedic procedures.
Product
10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES, CODE: INTVM-SCDK. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1770-2021·2021-06-09
Orthopedic Spinal Balloon Kit Recalled for Inadequate Sterilization Risk
Zavation's VERTEBREX single balloon kit for spinal procedures is being recalled because distributed units may not have been adequately sterilized, creating a potential infection risk.
Product
VERTEBREX SINGLE BALLOON KIT, REF VBRX-20-SBK-10. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1754-2021·2021-06-09
Orthopedic Bone Access Tools May Lack Proper Sterilization
Zavation is recalling InterV 10G Bone Access Tools (Lot 11613ZV) distributed nationwide because they may not have been adequately sterilized. No illnesses have been reported.
Product
InterV 10G Bone Access Tools/Kit, REF INTVM-FLNK. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1711-2021·2021-06-09
ZVplasty Direct Access Bevel Tip Trocar Recalled Due to Inadequate Sterilization
Zavation is recalling ZVplasty Direct Access Bevel Tip Trocars used in orthopedic and spinal procedures because products distributed as sterile may not have been adequately sterilized. The recall affects 98 units distributed nationwide.
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-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-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-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-1756-2021·2021-06-09
OsteoFlex Bone Cement Recalled Due to Inadequate Sterilization
Zavation's OsteoFlex bone cement distributed nationwide may not have been adequately sterilized. Patients who received this sterile surgical product in orthopedic or spinal procedures should contact their healthcare provider.
Product
OsteoFlex BONE CEMENT, REF Numbers: a) INTV-OSFL b) INTV-OSFL-LV. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1750-2021·2021-06-09
Zavation CEMIX Orthopedic Cement Mixing System Sterilization Recall
Zavation recalled 197 CEMIX cement mixing system units due to inadequate sterilization for orthopedic and spinal surgical use.
Product
CEMIX - CEMENT MIXING SYSTEM STERILE, CODE INTV-MMS. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1755-2021·2021-06-09
InterV 11G Kyphoplasty Kit Recall: Sterilization Defect May Increase Infection Risk
Zavation is recalling 119 InterV 11G Kyphoplasty Kits distributed nationwide because they may not have been adequately sterilized, which could increase the risk of infection during spinal surgery.
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.
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-1725-2021·2021-06-09
ZVplasty Directional Cement Cannula Long may lack adequate sterilization
Zavation is recalling 27 units of ZVplasty Directional Cement Cannula Long (Lot 20061365) used in orthopedic and spinal procedures due to inadequate sterilization. Products were distributed nationwide as sterile but may not have undergone proper sterilization processing.
Product
ZVplasty Directional Cement Cannula Long, REF VCF-1080-L. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1748-2021·2021-06-09
Zavation 10G Beveled Trocar/Cannula recalled for inadequate sterilization
Zavation is recalling 10G Beveled Trocar/Cannula surgical instruments distributed nationwide because they may not have been adequately sterilized. Patients who received these instruments in orthopedic or spinal procedures should consult their healthcare provider.
Product
10G BEVELED TROCAR/CANNULA. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1715-2021·2021-06-09
Orthopedic spinal surgical device may lack adequate sterilization
Zavation is recalling its 10G DIRECT SINGLE - ACCESS device used in spinal surgery. Products distributed as sterile may not have been adequately sterilized.
Product
10G DIRECT SINGLE - ACCESS, CODE INTVM-DSBAK. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1716-2021·2021-06-09
Zavation 10 Gauge Direct Access Diamond Tip Devices Recalled for Sterilization
Zavation is recalling 89 units of 10 Gauge Direct Access Diamond Tip devices (Lot 11285ZV, 2001200) distributed nationwide for orthopedic spinal procedures because they may not have been adequately sterilized.
Product
10 GAUGE DIRECT ACCESS DIAMOND TIP, CODE: INTVM-DWCd. 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-1702-2021·2021-06-09
ZVplasty Drill units may not have been adequately sterilized
Zavation recalled ZVplasty Drill units (REF VCF-1006, batch 19113036) distributed nationwide. The 38 affected units may not have been adequately sterilized, creating a risk of infection.
Product
ZVplasty Drill, 10 Gauge, REF VCF-1006. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1752-2021·2021-06-09
InterV Kyphoplasty Spinal Devices Recalled for Inadequate Sterilization
Zavation's InterV 10G FLEX Kyphoplasty spinal devices are recalled because they may not have been adequately sterilized. The recall affects 178 units distributed nationwide.
Product
InterV, 10G FLEX Kyphoplasty, REF Number: a) INTVM-15-FLDSK b) INTVM-20-FLDSK. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1704-2021·2021-06-09
Zavation ZVplasty Direct Access Diamond Tip Trocar may not be sterile
Zavation is recalling ZVplasty Direct Access Diamond Tip Trocar (REF VCF-1023) distributed nationwide because products marketed as sterile may not have been adequately sterilized. The device is used in orthopedic and spinal procedures.
Product
ZVplasty Direct Access Diamond Tip Trocar, 10 Gauge, REF VCF-1023. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide