The Recall Desk
HighFDA (Devices)·Z-1757-2021·Announced 2021-06-09

ZVplasty System spinal implant devices recalled for inadequate sterilization

Zavation is recalling 31 ZVplasty System spinal implant devices that may not have been adequately sterilized. Patients who received these implants should contact their physician.

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 recall of a surgical implant device with potential risk of infection from inadequate sterilization. No illnesses or injuries have been reported, placing it in the High severity category per the rubric criterion for risk-of-harm products without reported injury.

Plain-English summary

Zavation is recalling ZVplasty System 10mm devices (Patent VCF-1010-2) used in orthopedic and spinal procedures. The recall affects 31 units distributed nationwide in the United States.

The devices were distributed as sterile but may not have been adequately sterilized. Inadequate sterilization of surgical implants poses a potential risk of infection.

Patients who received devices from affected lot numbers 13403ZV, 14172ZV, 13723ZV, 13031ZV, or 10760ZV should contact their healthcare provider for guidance.

The recalled product

Product
ZVplasty System, 10mm, Pat# VCF-1010-2. For use in Orthopedic / spinal procedures.
Manufacturer
Zavation
Category
Medical Device — Orthopedic / Spinal
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 (5)

  • Lot Numbers: 13403ZV
  • 14172ZV
  • 13723ZV
  • 13031ZV
  • 10760ZV

Distribution

Distributed nationwide across the United States.

Related recalls

Same category