The Recall Desk
HighFDA (Devices)·Z-1761-2021·Announced 2021-06-09

Spinal surgery implant kit recalled for inadequate sterilization

Zavation is recalling ZVplasty 10G spinal implant kits that may not have been properly sterilized. The affected devices were distributed nationwide and may pose infection risk if implanted.

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 Class II recall involves a medical device intended for invasive spinal procedures where sterility is critical to patient safety. No illnesses or injuries have been reported, but inadequate sterilization poses a direct risk of serious infection.

Plain-English summary

Zavation has recalled the ZVplasty 10G, 15mm, Additional Level Kit (REF VCF-1015-1A) used in orthopedic spinal procedures. The products distributed as sterile may not have been adequately sterilized.

The recall covers lot number 12302ZV, representing 3 units distributed nationwide in the United States. Implantation of inadequately sterilized surgical devices poses a risk of infection.

Patients and healthcare providers who have this device should be aware of the sterilization issue and consult appropriate resources for guidance on next steps.

The recalled product

Product
ZVplasty 10G, 15mm, Additional Level Kit, REF VCF-1015-1A. For use in Orthopedic / spinal procedures.
Manufacturer
Zavation
Category
Medical Device — Orthopedic / Spinal Surgery
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 Numbers: 12302ZV

Distribution

Distributed nationwide across the United States.

Related recalls

Same category