Zavation ZVplasty Direct Access Diamond Tip Trocar may not be sterile
Zavation is recalling ZVplasty Direct Access Diamond Tip Trocar (REF VCF-1023) distributed nationwide because products marketed as sterile may not have been adequately sterilized. The device is 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 device with a sterilization defect. Although no illnesses or injuries have been reported, the device is used in spinal procedures where contamination poses a serious risk of infection. Per the severity rubric, risk-of-harm products where injury has not yet been reported merit a High severity score.
Plain-English summary
Zavation is recalling the ZVplasty Direct Access Diamond Tip Trocar, 10 Gauge (REF VCF-1023), a surgical instrument used in orthopedic and spinal procedures. The FDA has determined that the recalled products, distributed as sterile, may not have been adequately sterilized.
The recall affects 88 units with lot numbers 2004989 and 19113039 that were distributed nationwide in the United States.
Affected healthcare facilities and users should not use the recalled units in clinical procedures. Contact Zavation for instructions on return or replacement.
The recalled product
- Product
- ZVplasty Direct Access Diamond Tip Trocar, 10 Gauge, REF VCF-1023. For use in Orthopedic / spinal procedures.
- Manufacturer
- Zavation
- Hazard
- inadequate-sterilization
- contamination-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: 2004989
- 19113039
Distribution
Distributed nationwide across the United States.
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