The Recall Desk
HighFDA (Devices)·Z-1727-2021·Announced 2021-06-09

Orthopedic spinal surgical device recalled for inadequate sterilization

Zavation recalls orthopedic spinal devices distributed as sterile but potentially inadequately sterilized. Patients who received these devices should consult their healthcare provider.

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 medical device recall involving inadequate sterilization of a surgical instrument. No illnesses or injuries have been reported. Per the severity rubric, this qualifies as High (Score 3) as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Zavation has recalled the 10G DIRECT SINGLE - ACCESS orthopedic/spinal procedure device (Lot 20061432) due to inadequate sterilization. Products were distributed as sterile but may not have been adequately sterilized, increasing the risk of infection at the surgical site.

This recall affects the 24 units that were distributed nationwide in the United States. Patients who received this device during orthopedic or spinal procedures may be at risk.

Consult your healthcare provider immediately if you have received this device. Do not use any remaining units. Contact the recalling manufacturer for additional information about this recall.

The recalled product

Product
10G DIRECT SINGLE - ACCESS, CODE: INTV-DWCb. For use in Orthopedic / spinal procedures.
Manufacturer
Zavation
Category
Medical Device — Orthopedic / Spinal
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: 20061432

Distribution

Distributed nationwide across the United States.

Related recalls

Same category