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.
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: This FDA Class II recall involves sterile surgical instruments intended for invasive spinal procedures. Although no illnesses or injuries have been reported, inadequate sterilization of surgical cannulas represents a direct infection risk to patients, qualifying as a risk-of-harm product with injury not yet reported.
Plain-English summary
Zavation Medical Corporation is recalling 10-gauge cement delivery cannulas (code INTVM-CDC) used in orthopedic and spinal surgical procedures. The recalled devices, from lots 19112827 and 2002440, were distributed nationwide across the United States.
The products are being recalled because they were distributed as sterile medical devices but may not have been adequately sterilized. Non-sterile surgical instruments used in spinal procedures pose a risk of infection to patients undergoing these invasive procedures.
If you have received or used these devices, contact Zavation Medical Corporation or your healthcare facility immediately. Do not use any cannulas from the affected lots. Healthcare providers should consult FDA guidance on handling recalled medical devices.
The recalled product
- Product
- 10 GAUGE CEMENT DELIVERY CANNULA, CODE: INTVM-CDC. For use in Orthopedic / spinal procedures.
- Manufacturer
- Zavation
- Affected units
- 130
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 (2)
- Lot: 19112827
- 2002440
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