Spinal surgical cement delivery cannulas recalled for inadequate sterilization
Zavation is recalling 130 units of 10-gauge cement delivery cannulas used in spinal procedures due to inadequate sterilization. These devices may not be sterile, creating infection risk for surgical patients.
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 FDA Class II recall involves sterile surgical instruments intended for invasive spinal procedures. Although no illnesses or injuries have been reported, inadequate sterilization of surgical cannulas represents a direct infection risk to patients, qualifying as a risk-of-harm product with injury not yet reported.
Plain-English summary
Zavation Medical Corporation is recalling 10-gauge cement delivery cannulas (code INTVM-CDC) used in orthopedic and spinal surgical procedures. The recalled devices, from lots 19112827 and 2002440, were distributed nationwide across the United States.
The products are being recalled because they were distributed as sterile medical devices but may not have been adequately sterilized. Non-sterile surgical instruments used in spinal procedures pose a risk of infection to patients undergoing these invasive procedures.
If you have received or used these devices, contact Zavation Medical Corporation or your healthcare facility immediately. Do not use any cannulas from the affected lots. Healthcare providers should consult FDA guidance on handling recalled medical devices.
The recalled product
- Product
- 10 GAUGE CEMENT DELIVERY CANNULA, CODE: INTVM-CDC. For use in Orthopedic / spinal procedures.
- Manufacturer
- Zavation
- 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 (2)
- Lot: 19112827
- 2002440
Distribution
Distributed nationwide across the United States.
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