ZVplasty Unipedicular Cement Delivery Cannula Kit May Not Be Adequately Sterilized
Zavation recalls ZVplasty Unipedicular Cement Delivery Cannula Kit (72 units nationwide) due to sterilization failure. Products distributed as sterile may not have been adequately sterilized.
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: This is an FDA Class II medical device recall for sterilization failure of a surgical instrument. The product presents a risk of infection if used in procedures, meeting the rubric criterion for High severity as a risk-of-harm product without reported injury.
Plain-English summary
Zavation is recalling the ZVplasty Unipedicular Cement Delivery Cannula Kit, 10 Gauge (Model VCG-SCDK), used in orthopedic and spinal procedures. A total of 72 units were distributed nationwide in the United States.
The products were distributed with the representation that they are sterile. However, they may not have been adequately sterilized. Inadequate sterilization of surgical devices poses a risk of infection if the product is used in surgical procedures.
Patients and healthcare providers who have this product should contact Zavation or their healthcare provider. The affected lot numbers are: 2003661, 19113051, 20071709, and 20071843.
The recalled product
- Product
- ZVplasty Unipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCG-SCDK. For use in Orthopedic / spinal procedures.
- Manufacturer
- Zavation
- Affected units
- 72
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.
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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