The Recall Desk
HighFDA (Devices)·Z-1765-2021·Announced 2021-06-09

Orthopedic Spinal Procedure Kit Recalled for Inadequate Sterilization

Zavation's ZVplasty spinal surgical kit is being recalled because distributed units may not have been adequately sterilized. The recall affects 302 units distributed nationwide.

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 for potential inadequate sterilization. The source text indicates no reported illnesses or injuries, making this a risk-of-harm product where injury has not yet been reported, per the rubric criterion for a score of 3.

Plain-English summary

Zavation is recalling the ZVplasty 10G, 20mm, Traditional Unipedicular Kit (REF VCF-1020-1), a spinal surgical device used in orthopedic procedures. The units were distributed with a sterile designation, but they may not have been adequately sterilized.

This recall affects 302 units distributed nationwide. The affected devices carry one of 23 specific lot numbers. Healthcare facilities should verify whether they have received units from the affected lot numbers and contact Zavation or the FDA for guidance.

The recalled product

Product
ZVplasty 10G, 20mm, Traditional Unipedicular Kit, REF VCF-1020-1. For use in Orthopedic / spinal procedures.
Manufacturer
Zavation
Category
Medical Device — Spinal Surgery
Hazard
  • inadequate-sterilization

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 (20)

  • Lot Numbers: 13978ZV
  • 13966ZV
  • 13873ZV
  • 13643ZV
  • 13185ZV
  • 12594ZV
  • 11766ZV
  • 11548ZV
  • 11391ZV
  • 11139ZV
  • 10781ZV
  • 14390ZV
  • 13976ZV
  • 13711ZV
  • 13413ZV
  • 12930ZV
  • 12331ZV
  • 12300ZV
  • 12199ZV
  • 14349ZV

Distribution

Distributed nationwide across the United States.

Related recalls

Same category