The Recall Desk
HighFDA (Devices)·Z-1733-2021·Announced 2021-06-09

Zavation 10G Beveled Trocar/Cannula Recalled Due to Inadequate Sterilization

Zavation is recalling 10G beveled trocar/cannula instruments used in orthopedic and spinal procedures due to potential inadequate sterilization, creating infection 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: Class II medical device recall involving surgical instruments with potential inadequate sterilization, which poses a risk of harm to patients. No illnesses or injuries have been reported, making this a theoretical risk-of-harm scenario.

Plain-English summary

Zavation is recalling 10G beveled trocar/cannula surgical instruments that were distributed as sterile for use in orthopedic and spinal procedures. The recall was issued because the instruments may not have been adequately sterilized.

Trocars and cannulas are used to create access points during surgical procedures. If sterilization is inadequate, patients undergoing orthopedic or spinal surgery face a risk of surgical site infection.

The affected instruments were distributed nationwide in the United States. No illnesses or injuries have been reported in connection with this recall.

The recalled product

Product
10G BEVELED TROCAR/CANNULA. For use in Orthopedic / spinal procedures.
Manufacturer
Zavation
Category
Medical Device — Surgical Instruments / 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