Zavation recalls ZVplasty Diamond Tip Trocar due to sterilization failure
Zavation is recalling 113 units of ZVplasty Direct Access Diamond Tip Trocars (11 Gauge) due to inadequate sterilization. The devices were distributed nationwide and may not be safe for use 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: FDA Class II recall of surgical instruments with inadequate sterilization. No hospitalizations or injuries have been reported, making this a risk-of-harm situation without documented injury, consistent with severity score 3 (High).
Plain-English summary
Zavation is recalling 113 units of the ZVplasty Direct Access Diamond Tip Trocar, 11 Gauge (REF VCF-1023-11). This surgical instrument is designed for use in orthopedic and spinal procedures.
The devices were distributed as sterile but may not have been adequately sterilized. Inadequate sterilization of surgical instruments can result in infection during or after procedures.
The recall affects lot numbers 19123264 and 20071773, which were distributed nationwide in the United States.
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
- sterilization-failure
- 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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