The Recall Desk
HighFDA (Devices)·Z-1706-2021·Announced 2021-06-09

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
Category
Medical Device — Surgical / Orthopedic
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