The Recall Desk
HighFDA (Devices)·Z-1724-2021·Announced 2021-06-09

Zavation Surgical Trocars Recalled Due to Sterilization Concerns

Zavation recalled 98 surgical trocars that may not be adequately sterilized. Products were distributed as sterile but may pose infection risks from inadequate sterilization.

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 with no reported injuries or hospitalizations and a theoretical sterilization hazard warrant a High severity. Surgical instruments used in spinal procedures that may not be adequately sterilized pose an inherent risk of infection, qualifying this as a risk-of-harm product.

Plain-English summary

Zavation is recalling the ZVplasty Direct Access Bevel Tip Trocar, 11 Gauge (REF VCF-1022-11), a surgical instrument used in orthopedic and spinal procedures. The recall involves 98 units distributed nationwide under lot numbers 20061381, 20071771, and 19123263.

The products were distributed as sterile medical devices but may not have been adequately sterilized. This sterilization failure presents a risk of infection to patients who undergo procedures using affected instruments.

Healthcare facilities and patients who may have received these instruments should consult with their healthcare providers and Zavation regarding the recall.

The recalled product

Product
ZVplasty Direct Access Bevel Tip Trocar, 11 Gauge, REF VCF-1022-11. For use in Orthopedic / spinal procedures.
Manufacturer
Zavation
Category
Medical Device — Surgical Instrument
Hazard
  • sterilization-failure
  • 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 (3)

  • Lot: 20061381
  • 20071771
  • 19123263

Distribution

Distributed nationwide across the United States.

Related recalls

Same category