The Recall Desk
HighFDA (Devices)·Z-1743-2021·Announced 2021-06-09

10G Direct Single Bone Access Kits recalled for sterilization failure

Zavation's 10G Direct Single Bone Access Kits are being recalled because products distributed as sterile may not have been adequately sterilized, posing infection risk in orthopedic procedures.

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 for sterilization failure on surgical instruments used in spinal procedures represents significant infection risk. No illnesses or hospitalizations are reported in the source material, so severity is limited to High per the rubric.

Plain-English summary

Zavation is recalling the 10G Direct Single Bone Access Kit, a sterile medical device used in orthopedic and spinal surgery procedures. The device was distributed nationwide in the United States.

The recall was issued because products distributed as sterile may not have been adequately sterilized. Non-sterile surgical instruments pose a potential infection risk to patients undergoing procedures.

Patients who have received procedures with this device and healthcare facilities with this kit in inventory should contact Zavation for guidance on whether their lot is affected and what corrective actions may be necessary.

The recalled product

Product
10G DIRECT SINGLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.
Manufacturer
Zavation
Category
Medical Device — Orthopedic Surgical Instruments
Hazard
  • sterilization-failure
  • infection

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