ZVplasty Drill units may not have been adequately sterilized
Zavation recalled ZVplasty Drill units (REF VCF-1006, batch 19113036) distributed nationwide. The 38 affected units may not have been adequately sterilized, creating a risk of infection.
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 a sterile product with unconfirmed sterilization failure, creating a risk of infection. No illnesses or injuries have been reported. This meets the High severity criterion: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Zavation has recalled ZVplasty Drill, 10 Gauge (REF VCF-1006), a sterile medical device used in orthopedic and spinal procedures. The recall was initiated because the affected units may not have been adequately sterilized, which could compromise the device's sterility and increase the risk of infection.
The recalled product was distributed throughout the United States. The recall involves 38 units with batch code 19113036.
The recalled product
- Product
- ZVplasty Drill, 10 Gauge, REF VCF-1006. For use in Orthopedic / spinal procedures.
- Manufacturer
- Zavation
- Affected units
- 38
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 (1)
- Product batch: 19113036
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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