The Recall Desk
HighFDA (Devices)·Z-1736-2021·Announced 2021-06-09

11G Beveled Trocars and Cannulas Recalled for Possible Inadequate Sterilization

Zavation is recalling 11G Beveled Trocars/Cannulas for orthopedic and spinal procedures. These surgical instruments may not have been adequately sterilized, posing a potential safety risk.

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 an FDA Class II recall for surgical instruments that may not have been adequately sterilized. No reported injuries or hospitalizations are documented in the source. However, non-sterile surgical instruments present a significant risk of infection to surgical patients, meeting the criteria for a risk-of-harm product without yet-reported injury.

Plain-English summary

Zavation is recalling 11G Beveled Trocars/Cannulas for orthopedic and spinal surgical procedures. These instruments are intended to be sterile and for single-use application.

The recall was initiated because the distributed products may not have been adequately sterilized. The FDA classified this as a Class II recall. The affected instruments were distributed nationwide in the United States.

Non-sterile surgical instruments present a potential risk of infection to patients.

The recalled product

Product
11G BEVELED TROCAR/CANNULA. 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)

  • Pending

Distribution

Distributed nationwide across the United States.

Related recalls

Same category