ZVplasty Spinal Bone Access Kit Recall Due to Inadequate Sterilization
Zavation is recalling ZVplasty Direct Bipedicular Bone Access Kits due to inadequate sterilization. Products distributed as sterile nationwide may pose infection risk if used in spinal procedures.
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 a Class II medical device recall with no reported illnesses or injuries. However, it involves a risk-of-harm product (surgical instrument for spinal procedures) where injury has not yet been reported due to sterilization failure. Per the severity rubric, this meets criteria for High (3) severity.
Plain-English summary
Zavation is recalling the ZVplasty Direct Bipedicular Bone Access Kit with Drill (10 Gauge, model VCF-DDBAK), a surgical instrument used in orthopedic and spinal procedures. Products were distributed as sterile but may not have been adequately sterilized, creating a risk of surgical site infection.
The affected lot numbers are 20071860, 2004988, 19113040, and 20071775. The product was distributed nationwide throughout the United States.
The recalled product
- Product
- ZVplasty Direct Bipedicular Bone Access Kit with Drill, 10 Gauge, VCF-DDBAK. For use in Orthopedic / spinal procedures.
- Manufacturer
- Zavation
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: 20071860
- 2004988
- 19113040
- 20071775
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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