Zavation ZVplasty Double Balloon Kit Recalled Due to Inadequate Sterilization
Zavation recalls ZVplasty 10G, 10mm Double Balloon Kits used in spinal surgery due to potential inadequate sterilization. Seven units distributed nationwide may not have met sterility standards.
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 medical device recall due to sterilization failure of a spinal surgical instrument. No illnesses or injuries reported; the hazard is theoretical. Per the rubric, no reported illnesses with theoretical hazard yields a maximum score of 3.
Plain-English summary
Zavation is recalling ZVplasty 10G, 10mm Double Balloon Kits (Reference VCF-1010-DBK), a medical device used in orthopedic and spinal procedures. The recall affects seven units with lot numbers 12872ZV, 12406ZV, and 11934ZV.
The recall was initiated because the affected products, which were distributed as sterile, may not have been adequately sterilized. Inadequate sterilization of surgical devices poses a risk of bacterial contamination and potential infection in patients undergoing spinal procedures.
These kits were distributed nationwide throughout the United States to medical facilities and surgical centers.
Healthcare providers and facilities using this product should immediately discontinue use of the affected lot numbers and contact Zavation for instructions on replacement or proper disposal. Patients who have received implants from affected units should consult with their healthcare provider.
The recalled product
- Product
- ZVplasty, 10G, 10mm Double Balloon Kit, REF VCF-1010-DBK. 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 (3)
- Lot Numbers: 12872ZV
- 12406ZV
- 11934ZV
Distribution
Distributed nationwide across the United States.
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