The Recall Desk
HighFDA (Devices)·Z-1702-2021·Announced 2021-06-09

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.

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 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
Category
Medical Device — Orthopedic/Surgical
Hazard
  • sterilization-failure
  • 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 (1)

  • Product batch: 19113036

Distribution

Distributed nationwide across the United States.

Related recalls

Same category