ZVplasty Bone Access Kit Recalled for Inadequate Sterilization
Zavation has recalled the ZVplasty Direct Unipedicular Bone Access Kit with Drill due to potential sterilization failure. The surgical device is used in orthopedic and spinal procedures, with 11 units distributed nationwide.
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 recall involving potential sterilization failure on surgical instruments used in patient procedures. While no illnesses or injuries have been reported, inadequate sterilization of orthopedic surgical tools presents a theoretical risk of infection, meeting the High severity threshold for risk-of-harm products without documented injury.
Plain-English summary
Zavation has recalled the ZVplasty Direct Unipedicular Bone Access Kit with Drill, 10 Gauge (REF VCF-DSBAK), used in orthopedic and spinal procedures. A total of 11 units were distributed nationwide. The recall was initiated because products distributed as sterile may not have been adequately sterilized.
The affected lot numbers are 19113041, 20071853, 20071714, and 2003803. Sterilization failure creates a potential risk of infection when these instruments are used in surgical procedures.
Healthcare facilities and practitioners who have received these kits should verify lot numbers and take appropriate action to prevent potential patient harm.
The recalled product
- Product
- ZVplasty Direct Unipedicular Bone Access Kit with Drill, 10 Gauge, REF VCF-DSBAK. For use in Orthopedic / spinal procedures.
- Manufacturer
- Zavation
- Affected units
- 11
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: 19113041
- 20071853
- 20071714
- 2003803
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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