The Recall Desk
HighFDA (Devices)·Z-1734-2021·Announced 2021-06-09

Zavation 10G Direct Single Bone Access Kit Recall Due to Inadequate Sterilization

Zavation is recalling its 10G Direct Single Bone Access Kit because some units distributed as sterile may not have been adequately sterilized. The kit is used in orthopedic and spinal procedures and was distributed nationwide.

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 of a sterile surgical device with confirmed inadequate sterilization. Although no illnesses or injuries have been reported, the product represents a risk-of-harm scenario for patients undergoing invasive orthopedic and spinal procedures, meeting the criterion for High severity.

Plain-English summary

Zavation is recalling the 10G Direct Single Bone Access Kit, a surgical instrument used in orthopedic and spinal procedures. The product was distributed nationwide in the United States.

Some products distributed as sterile may not have been adequately sterilized. Non-sterile surgical instruments used in orthopedic and spinal procedures may increase the risk of infection for patients.

The recalled product

Product
10G DIRECT SINGLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.
Manufacturer
Zavation
Category
Medical Device — Orthopedic / Spinal Surgery Equipment
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