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.
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 recall of sterile surgical devices used in spinal procedures with potential sterilization failure. No illnesses or injuries have been reported. Per rubric, a risk-of-harm product where injury has not been reported scores 3 (High).
Plain-English summary
Zavation Medical is recalling the ZVplasty Unipedicular Cement Delivery Cannula Kit, 10 Gauge (REF VCF-SCDK), a sterile medical device used in orthopedic and spinal procedures. The recall affects 72 units distributed nationwide.
The recall was initiated because products distributed as sterile may not have been adequately sterilized. This creates a potential risk of infection in patients who undergo spinal procedures using these devices.
The affected lot numbers are 2003661, 19113051, 20071709, and 20071843. These devices were distributed throughout the United States.
The recalled product
- Product
- ZVplasty Unipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCF-SCDK. For use in Orthopedic / spinal procedures.
- Manufacturer
- Zavation
- Hazard
- inadequate-sterilization
- infection-risk
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 (4)
- Lot: 2003661
- 19113051
- 20071709
- 20071843
Distribution
Distributed nationwide across the United States.
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