The Recall Desk
HighFDA (Devices)·Z-1726-2021·Announced 2021-06-09

ZVplasty Directional Cement Cannula recalled for inadequate sterilization

Zavation is recalling 11 units of ZVplasty Directional Cement Cannula from lot 20061366 because products distributed as sterile may not have been adequately sterilized. The affected devices 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 surgical devices with sterilization failure, which is a risk-of-harm product where no injuries have been reported. Inadequate sterilization of devices used in spinal procedures poses significant infection risk, meeting the rubric criterion for Score 3.

Plain-English summary

Zavation is recalling 11 units of ZVplasty Directional Cement Cannula (REF VCF-1080-S4, lot 20061366). These sterile medical devices are used in orthopedic and spinal procedures. The recall was initiated because products distributed as sterile may not have been adequately sterilized.

The affected devices were distributed nationwide in the United States.

Patients who received treatment with an affected device should consult their healthcare provider. For more information about the recall, contact Zavation or the FDA.

The recalled product

Product
ZVplasty Directional Cement Cannula (4 pieces per pack), REF VCF-1080-S4. For use in Orthopedic / spinal procedures.
Manufacturer
Zavation
Category
Medical Device — Surgical / Orthopedic
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: 20061366

Distribution

Distributed nationwide across the United States.

Related recalls

Same category