The Recall Desk
HighFDA (Devices)·Z-1731-2021·Announced 2021-06-09

10 Gauge Drill for Orthopedic Surgery Recalled for Sterilization Failure

Zavation recalled 58 units of 10 Gauge Drill (Lot 20102486) used in orthopedic/spinal procedures due to potential inadequate sterilization. Patients should contact their surgeon if they received treatment with an affected device.

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 inadequate sterilization of surgical instruments used in spinal procedures. This is a risk-of-harm product where injury has not yet been reported, meeting the rubric criteria for High severity.

Plain-English summary

Zavation has recalled 58 units of its 10 Gauge Drill (model INTVM-DRL, Lot 20102486) used in orthopedic and spinal procedures. The devices were distributed nationwide and marketed as sterile products.

The FDA classified this as a Class II recall. The issue is that products distributed as sterile may not have been adequately sterilized.

Patients who underwent orthopedic or spinal procedures should consult their healthcare provider to determine whether they may have received treatment with an affected device.

The recalled product

Product
10 Gauge Drill, CODE: INTVM-DRL. For use in Orthopedic / spinal procedures.
Manufacturer
Zavation
Category
Medical Device — Surgical / Orthopedic
Hazard
  • sterilization-failure

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: 20102486

Distribution

Distributed nationwide across the United States.

Related recalls

Same category