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.
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 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
- 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: 20071860
- 2004988
- 19113040
- 20071775
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03