ZVplasty Direct Access Trocar Recalled for Inadequate Sterilization
Zavation is recalling ZVplasty Direct Access Diamond Tip Trocars (11 Gauge) because some units may not be adequately sterilized. These surgical instruments are used in orthopedic and spinal procedures.
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 used in invasive spinal procedures. The hazard—inadequate sterilization—poses a direct risk of infection, qualifying as a risk-of-harm product. No illnesses or injuries have been reported, placing it below the Severe threshold which requires hospitalization reports or documented harm.
Plain-English summary
Zavation is recalling 113 ZVplasty Direct Access Diamond Tip Trocars (11 Gauge, REF VCF-1023-11) distributed nationwide in the United States. These surgical instruments were distributed as sterile but may not have been adequately sterilized. Lot numbers affected are 19123264 and 20071773.
These trocars are used in orthopedic and spinal procedures. Non-sterile surgical instruments used in invasive spinal procedures pose a risk of infection to patients.
Healthcare facilities that received affected units should stop using them immediately and contact Zavation. Patients who have undergone procedures using these instruments should consult their healthcare provider if they develop signs of infection.
The recalled product
- Product
- ZVplasty Direct Access Diamond Tip Trocar, 11 Gauge, REF VCF-1023-11. 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: 19123264
- 20071773
Distribution
Distributed nationwide across the United States.
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