The Recall Desk
HighFDA (Devices)·Z-1732-2021·Announced 2021-06-09

ZVplasty Cement Delivery Cannula Recalled Due to Sterilization Failure

Zavation recalls 22 ZVplasty Cement Delivery Cannulas (lot 20102490) distributed nationwide because they may not have been adequately sterilized for use in orthopedic and spinal procedures.

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: FDA Class II medical device recall with no reported illnesses or injuries to date. The hazard—inadequate sterilization of surgical cannulas—presents a credible infection risk for high-risk orthopedic procedures, but without documented patient harm.

Plain-English summary

Zavation Medical is recalling 22 units of the ZVplasty Cement Delivery Cannula (REF VCF-1007, lot 20102490) that were distributed nationwide for use in orthopedic and spinal procedures. The devices were distributed as sterile but may not have been adequately sterilized.

The inadequate sterilization of these medical devices creates a risk of infection if used in surgical procedures. Healthcare facilities that received this lot should identify affected products and contact Zavation or their medical device supplier immediately.

Patients who underwent orthopedic or spinal procedures using affected cannulas from this lot should consult their healthcare provider if they experience signs of infection or other complications.

The recalled product

Product
ZVplasty Cement Delivery Cannula, REF VCF-1007. 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: 20102490

Distribution

Distributed nationwide across the United States.

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