The Recall Desk
HighFDA (Devices)·Z-1740-2021·Announced 2021-06-09

Zavation Orthopedic Cement Delivery Kit Recalled for Inadequate Sterilization

Zavation is recalling its 10G Single Cement Delivery Kit used in spinal procedures because products distributed as sterile may not have been adequately sterilized. This is an FDA Class II recall.

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 recall of a sterile surgical device with potential infection risk from inadequate sterilization. No reported illnesses or injuries. Per the rubric, this is a risk-of-harm product without reported injury, scoring as High.

Plain-English summary

Zavation is recalling its 10G Single Cement Delivery Kit (5 Fillers), a sterile medical device used in orthopedic and spinal surgical procedures, because the recalled products may not have been adequately sterilized.

The affected device was distributed nationwide in the United States. The FDA classified this as a Class II recall. Specific lot numbers and distribution dates are pending.

The recalled product

Product
10G SINGLE CEMENT DELIVERY KIT (5 FILLERS). For use in Orthopedic / spinal procedures.
Manufacturer
Zavation
Category
Medical Device — Orthopedic
Hazard
  • inadequate-sterilization
  • contamination

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