The Recall Desk
HighFDA (Devices)·Z-1745-2021·Announced 2021-06-09

10G Coaxial Cannulas Recalled Due to Inadequate Sterilization in Spinal Procedures

Zavation's 10G Coaxial Cannulas for spinal procedures may not have been adequately sterilized. The nationwide recall addresses potential infection risk from non-sterile surgical instruments.

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 with potential serious hazard (infection risk from non-sterile surgical instruments in spinal procedures). No illnesses or injuries reported in source, qualifying this as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Zavation recalled 10G Coaxial Cannulas with Tuohy connection, sterile medical devices used in orthopedic and spinal procedures. The firm distributed these cannulas but determined that some units may not have been adequately sterilized.

Inadequate sterilization of surgical instruments poses a potential infection risk to patients. This is of particular concern for spinal procedures, where any contamination of the surgical field can have serious consequences.

The recalled devices were distributed nationwide throughout the United States. Healthcare providers and patients who may have received these devices should be aware of this recall.

The recalled product

Product
10G COAXIAL CANNULA WITH TUOHY CONNECTION STERILE. For use in Orthopedic / spinal procedures.
Manufacturer
Zavation
Category
Medical Device — Surgical Instruments - Spinal
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 (1)

  • Pending

Distribution

Distributed nationwide across the United States.

Related recalls

Same category