The Recall Desk
HighFDA (Devices)·Z-1747-2021·Announced 2021-06-09

Zavation 10G Cement Delivery Cannula Recalled for Inadequate Sterilization

Zavation is recalling its 10G Cement Delivery Cannula used in orthopedic and spinal procedures nationwide due to products distributed as sterile not being adequately sterilized.

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 medical device recall with no illnesses or injuries reported. The hazard—inadequate sterilization of a surgical device—represents a risk of harm in a high-risk application (spinal procedures), meeting the criterion for High severity when injury has not yet been reported.

Plain-English summary

Zavation is recalling the 10G Cement Delivery Cannula, a medical device used in orthopedic and spinal procedures. The device was distributed nationwide throughout the United States.

The product was distributed as sterile, but may not have been adequately sterilized. This poses a potential risk of infection or contamination when the device is used in surgical procedures.

Patients and healthcare providers who have this device should stop using it immediately and contact their healthcare provider for guidance on next steps. Zavation should be contacted regarding return and replacement of affected units.

The recalled product

Product
10G CEMENT DELIVERY CANNULA. For use in Orthopedic / spinal procedures.
Manufacturer
Zavation
Category
Medical Device — Orthopedic / Spinal Surgery
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