The Recall Desk
HighFDA (Devices)·Z-1754-2021·Announced 2021-06-09

Orthopedic Bone Access Tools May Lack Proper Sterilization

Zavation is recalling InterV 10G Bone Access Tools (Lot 11613ZV) distributed nationwide because they may not have been adequately sterilized. No illnesses have been reported.

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 involving surgical instruments with a sterilization failure. No illnesses or injuries have been reported; however, inadequate sterilization of orthopedic surgical tools presents a risk of harm in the surgical setting, meeting the High (3) criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Zavation is recalling the InterV 10G Bone Access Tools/Kit (reference number INTVM-FLNK) used in orthopedic and spinal procedures. The recall affects products from Lot 11613ZV that were distributed nationwide in the United States.

The products were distributed as sterile but may not have been adequately sterilized. This creates a potential risk of contamination if used in surgical procedures.

Healthcare facilities and providers that received this lot number should stop using the affected tools immediately. Contact Zavation for instructions on return or replacement of the affected lot.

The recalled product

Product
InterV 10G Bone Access Tools/Kit, REF INTVM-FLNK. For use in Orthopedic / spinal procedures.
Manufacturer
Zavation
Category
Medical Device — Orthopedic / Spinal Surgery
Hazard
  • sterilization-failure
  • contamination-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)

  • Lot Numbers: 11613ZV

Distribution

Distributed nationwide across the United States.

Related recalls

Same category