The Recall Desk
HighFDA (Devices)·Z-1723-2021·Announced 2021-06-09

ZVplasty Biopsy Device Recalled Due to Inadequate Sterilization

Zavation's ZVplasty Biopsy Device (11 Gauge, lot 20061370) is being recalled because distributed units may not have been adequately sterilized. The 34 affected units were 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 recall of a medical device used in invasive spinal procedures with a sterilization defect. While no illnesses or injuries have been reported in the source material, inadequate sterilization represents a significant risk-of-harm to patients. The score is 3 (High) per the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Zavation is recalling the ZVplasty Biopsy Device, 11 Gauge (REF VCF-1010-11), intended for use in orthopedic and spinal procedures. The recalled lot (20061370) consists of 34 units that were distributed nationwide.

The recall was initiated because the products, which were distributed as sterile, may not have been adequately sterilized. Inadequate sterilization of instruments used in invasive spinal procedures poses a risk of infection to patients.

The recalled product

Product
ZVplasty Biopsy Device, 11 Gauge, REF VCF-1010-11. For use in Orthopedic / spinal procedures.
Manufacturer
Zavation
Category
Medical Device — Surgical Instruments / Biopsy Device
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 (1)

  • Lot: 20061370

Distribution

Distributed nationwide across the United States.

Related recalls

Same category