The Recall Desk
HighFDA (Devices)·Z-1705-2021·Announced 2021-06-09

ZVplasty Cement Delivery Cannulas Recalled for Inadequate Sterilization

Zavation recalled 14 units of ZVplasty Bipedicular Cement Delivery Cannula Kits distributed nationwide 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 a Class II recall for inadequate sterilization of surgical instruments used in invasive spinal procedures. No illnesses or injuries have been reported. The hazard is theoretical but significant given the surgical application.

Plain-English summary

Zavation is recalling ZVplasty Bipedicular Cement Delivery Cannula Kits (10 Gauge, REF VCF-DCDK) due to a sterilization issue. The kits were distributed as sterile but may not have been adequately sterilized.

These devices are used in orthopedic and spinal surgical procedures. The recalled lot includes 14 units (lot 20081885) that were distributed nationwide in the United States.

Medical facilities and healthcare providers who received these devices should verify their lot numbers and contact Zavation to determine whether their units are affected and receive appropriate guidance.

The recalled product

Product
ZVplasty, Bipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCF-DCDK. For use in Orthopedic / spinal procedures.
Manufacturer
Zavation
Category
Medical Device — Surgical / Orthopedic Instruments
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 (1)

  • lot: 20081885

Distribution

Distributed nationwide across the United States.

Related recalls

Same category