The Recall Desk
HighFDA (Devices)·Z-1746-2021·Announced 2021-06-09

Zavation 10 Gauge Sterile Surgical Drill Recalled for Inadequate Sterilization

Zavation is recalling 10 gauge sterile surgical drills used in orthopedic and spinal procedures because products distributed as sterile may not have been adequately sterilized. Products were 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 surgical instrument where sterilization may be inadequate. No illnesses or injuries have been reported, but the risk-of-harm is significant given the product's use in invasive orthopedic and spinal procedures.

Plain-English summary

Zavation is recalling 10 gauge sterile surgical drills intended for use in orthopedic and spinal procedures. The company has determined that products distributed as sterile may not have been adequately sterilized.

These surgical drills were distributed nationwide. Inadequate sterilization of medical devices used in surgical procedures raises a potential risk of infection.

The recalled product

Product
10 GAUGE DRILL STERILE. For use in Orthopedic / spinal procedures.
Manufacturer
Zavation
Category
Medical Device — Orthopedic/Surgical
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