ZVplasty Cement Delivery Cannula Recalled Due to Sterilization Failure
Zavation recalls 22 ZVplasty Cement Delivery Cannulas (lot 20102490) distributed nationwide because they may not have been adequately sterilized for use in orthopedic and spinal procedures.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall with no reported illnesses or injuries to date. The hazard—inadequate sterilization of surgical cannulas—presents a credible infection risk for high-risk orthopedic procedures, but without documented patient harm.
Plain-English summary
Zavation Medical is recalling 22 units of the ZVplasty Cement Delivery Cannula (REF VCF-1007, lot 20102490) that were distributed nationwide for use in orthopedic and spinal procedures. The devices were distributed as sterile but may not have been adequately sterilized.
The inadequate sterilization of these medical devices creates a risk of infection if used in surgical procedures. Healthcare facilities that received this lot should identify affected products and contact Zavation or their medical device supplier immediately.
Patients who underwent orthopedic or spinal procedures using affected cannulas from this lot should consult their healthcare provider if they experience signs of infection or other complications.
The recalled product
- Product
- ZVplasty Cement Delivery Cannula, REF VCF-1007. For use in Orthopedic / spinal procedures.
- Manufacturer
- Zavation
- Affected units
- 22
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot: 20102490
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 71 recalled by Zavation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 71 products in this recall →Related recalls
Same manufacturer · Zavation
See all →- HighZavation 10G Direct Double Bone Access Kit May Not Be Properly Sterilized
FDA (Devices) · 2021-06-09
- HighZVplasty System spinal implant recalled due to inadequate sterilization
FDA (Devices) · 2021-06-09
- HighZVplasty orthopedic surgical devices may lack adequate sterilization
FDA (Devices) · 2021-06-09
- HighZavation Orthopedic Cement Delivery Kit Recalled for Inadequate Sterilization
FDA (Devices) · 2021-06-09
- HighOrthopedic bone access kits recalled for inadequate sterilization
FDA (Devices) · 2021-06-09
Same hazard · inadequate sterilization
See all →- HighBD Medical Extension Sets Recalled for Potential Sterilization Defects
FDA (Devices) · 2026-08-19
- HighOlympus Toomey Evacuator 30cc medical device sterilization parameters recalled
FDA (Devices) · 2026-07-22
- HighKarl Storz Ureteroscope Recall Due to Unapproved Reprocessing Instructions
FDA (Devices) · 2025-02-05
- HighMedline procedure kits recalled for surgical masks failing sterilization tests
FDA (Devices) · 2025-02-05
- ModerateKarl Storz Hopkins Telescope 6 endoscope recalled for unapproved reprocessing instructions
FDA (Devices) · 2024-10-02