The Recall Desk
HighFDA (Devices)·Z-1715-2021·Announced 2021-06-09

Orthopedic spinal surgical device may lack adequate sterilization

Zavation is recalling its 10G DIRECT SINGLE - ACCESS device used in spinal surgery. Products distributed as sterile may not have been adequately sterilized.

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 a Class II medical device recall for sterile surgical instruments that may lack adequate sterilization. While no injuries have been reported, inadequate sterilization of surgical instruments used in spinal procedures poses a direct risk of infection to patients, meeting the criteria for high-risk products where injury has not yet been reported.

Plain-English summary

Zavation is recalling the 10G DIRECT SINGLE - ACCESS device (product code INTVM-DSBAK) used in orthopedic and spinal surgical procedures. The product was distributed as sterile but may not have been adequately sterilized.

Surgical instruments that lack adequate sterilization pose a risk of infection to patients. The recalled device was distributed nationwide throughout the United States.

The recall affects lot 20051288, which includes 2 units. Patients and healthcare providers who have received or implanted this device should consult with their physician regarding appropriate follow-up care.

The recalled product

Product
10G DIRECT SINGLE - ACCESS, CODE INTVM-DSBAK. For use in Orthopedic / spinal procedures.
Manufacturer
Zavation
Category
Medical Device — Surgical instruments - spinal/orthopedic
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)

  • Lot: 20051288

Distribution

Distributed nationwide across the United States.

Related recalls

Same category