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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 due to sterilization failure. Although no illnesses or injuries have been reported, inadequate sterilization of equipment used in spinal procedures presents a direct risk of infection and serious harm to patients.
Plain-English summary
The product is the ZVplasty Bipedicular Cement Delivery Cannula, 11 Gauge, used in orthopedic and spinal procedures to deliver cement. The manufacturer, Zavation, distributed Lot 19123174 nationwide in the United States.
The recall was initiated because products labeled and distributed as sterile may not have been adequately sterilized. This means medical professionals performing spinal procedures may have unknowingly used non-sterile equipment.
Consumers who have received spinal procedures using this product should monitor for signs of infection and consult their healthcare provider if they experience any complications. Patients should contact their healthcare provider if they have questions about whether this product was used in their procedure. Healthcare facilities that have this product should discontinue use and contact Zavation for instructions on returns or replacement.
The recalled product
- Product
- ZVplasty Bipedicular Cement Delivery Cannula, 11 Gauge, REF VCF-DCDK-11. For use in Orthopedic / spinal procedures.
- Manufacturer
- Zavation
- Affected units
- 1
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: 19123174
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
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