The Recall Desk
HighFDA (Devices)·Z-1709-2021·Announced 2021-06-09

ZVplasty Unipedicular Cement Delivery Cannula Kit May Not Be Adequately Sterilized

Zavation recalls ZVplasty Unipedicular Cement Delivery Cannula Kit (72 units nationwide) due to sterilization failure. Products distributed as sterile may not have been adequately sterilized.

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 sterilization failure of a surgical instrument. The product presents a risk of infection if used in procedures, meeting the rubric criterion for High severity as a risk-of-harm product without reported injury.

Plain-English summary

Zavation is recalling the ZVplasty Unipedicular Cement Delivery Cannula Kit, 10 Gauge (Model VCG-SCDK), used in orthopedic and spinal procedures. A total of 72 units were distributed nationwide in the United States.

The products were distributed with the representation that they are sterile. However, they may not have been adequately sterilized. Inadequate sterilization of surgical devices poses a risk of infection if the product is used in surgical procedures.

Patients and healthcare providers who have this product should contact Zavation or their healthcare provider. The affected lot numbers are: 2003661, 19113051, 20071709, and 20071843.

The recalled product

Product
ZVplasty Unipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCG-SCDK. For use in Orthopedic / spinal procedures.
Manufacturer
Zavation
Category
Medical Device — Orthopedic / Spinal 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 (4)

  • Lot: 2003661
  • 19113051
  • 20071709
  • 20071843

Distribution

Distributed nationwide across the United States.

Related recalls

Same category