The Recall Desk
HighFDA (Devices)·Z-1722-2021·Announced 2021-06-09

ZVplasty Biopsy Device Lot 20061369 Recalled for Inadequate Sterilization

Zavation is recalling 162 units of the ZVplasty Biopsy Device (Lot 20061369) used in orthopedic and spinal procedures because they 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 a surgical device used in orthopedic and spinal procedures. The hazard—inadequate sterilization—poses a risk of serious infection. No illnesses or injuries have been reported, making this a risk-of-harm situation without documented injury.

Plain-English summary

Zavation is recalling 162 units of the ZVplasty Biopsy Device, 10 Gauge (REF VCF-1010), designed for use in orthopedic and spinal procedures. The affected lot is 20061369 and was distributed nationwide.

According to the FDA, products from this lot were distributed as sterile but may not have been adequately sterilized. Inadequate sterilization poses a potential infection risk when these devices are used in surgical procedures.

Patients who have undergone orthopedic or spinal procedures using the ZVplasty Biopsy Device from the affected lot should be aware of this recall. Healthcare providers should contact Zavation for specific guidance and recall information.

The recalled product

Product
ZVplasty Biopsy Device, 10 Gauge, REF VCF-1010. For use in Orthopedic / spinal procedures.
Manufacturer
Zavation
Category
Medical Device — Orthopedic / Spinal
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: 20061369

Distribution

Distributed nationwide across the United States.

Related recalls

Same category