The Recall Desk
HighFDA (Devices)·Z-1767-2021·Announced 2021-06-09

ZVPlasty Orthopedic Spinal Device Recalled for Inadequate Sterilization

Zavation is recalling ZVPlasty spinal orthopedic devices that may not have been properly sterilized, creating a risk of infection. The recall affects 49 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 risk-of-harm product—a spinal surgical device—where sterilization failure could result in serious infection. No illnesses or injuries have been reported. FDA Class II classification without hospitalization reports places this at score 3 per the rubric.

Plain-English summary

Zavation Medical has recalled the ZVPlasty, 11G, 15mm Traditional Bipedicular Kit (Reference VCF-1115-2), used in orthopedic and spinal surgery procedures. Forty-nine units were distributed nationwide across the United States.

The devices are being recalled because they were distributed as sterile but may not have been adequately sterilized. Non-sterile surgical devices used in spinal procedures pose a potential risk of infection.

Affected lot numbers are 11958ZV, 14393ZV, 11726ZV, 11107ZV, and 10955ZV. Healthcare providers should verify whether they have devices from these lots and take appropriate action.

The recalled product

Product
ZVPlasty, 11G, 15mm Traditional Bipedicular Kit, REF VCF-1115-2. For use in Orthopedic / spinal procedures.
Manufacturer
Zavation
Category
Medical Device — Orthopedic / Spinal
Hazard
  • sterilization-failure
  • contamination-risk
  • 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 (5)

  • Lot Numbers: 11958ZV
  • 14393ZV
  • 11726ZV
  • 11107ZV
  • 10955ZV

Distribution

Distributed nationwide across the United States.

Related recalls

Same category