Zavation Vertebrex Spinal Balloon Kit May Not Be Properly Sterilized
Zavation has recalled 140 units of its Vertebrex Single Balloon Kit used in spinal procedures due to inadequate sterilization. Products marketed as sterile may not meet 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: This is an FDA Class II medical device recall due to inadequate sterilization of a surgical device. No illnesses, injuries, or deaths are mentioned in the source. Per the rubric, this qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Zavation is recalling the Vertebrex Single Balloon Kit (reference VBRX-15-SBK-10), a medical device designed for use in orthopedic and spinal procedures. The recall affects 140 units distributed nationwide across the United States. The recalled products were marketed as sterile but may not have been adequately sterilized.
Healthcare providers and facilities that received this device should immediately check their inventory against the lot numbers identified in this recall (10085ZV, 10086ZV, 11205ZV, 11217ZV, 11554ZV, 11558ZV, 11559ZV). Any units matching these lot numbers should not be used. Facilities should contact Zavation for information about replacement or return.
The recalled product
- Product
- VERTEBREX SINGLE BALLOON KIT, REF VBRX-15-SBK-10. For use in Orthopedic / spinal procedures.
- Manufacturer
- Zavation
- Affected units
- 140
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 (7)
- Lot Numbers: 10085ZV
- 10086ZV
- 11205ZV
- 11217ZV
- 11554ZV
- 11558ZV
- 11559ZV
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 71 recalled by Zavation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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