Zavation Spinal Balloon Kit Recall Due to Inadequate Sterilization
Zavation is recalling 79 units of the ZVplasty 10G, 15mm Single Balloon Kit due to inadequate sterilization. Affected devices may pose a contamination risk for patients undergoing spinal procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 for a sterile medical device (spinal balloon kit) with confirmed sterilization failure. No illnesses or injuries are reported in the source material. Per the rubric, risk-of-harm products without reported injury are classified as High severity.
Plain-English summary
Zavation is recalling 79 units of the ZVplasty 10G, 15mm Single Balloon Kit (REF VCF-SBK) nationwide. The product is designed for use in orthopedic and spinal procedures.
The products were distributed as sterile medical devices but may not have been adequately sterilized. This sterilization failure poses a contamination risk for patients undergoing the procedures for which the device is intended.
The affected lot numbers are: 13877ZV, 13661ZV, 13388ZV, 12897ZV, 12764ZV, 12542ZV, 14391ZV, 14287ZV, 13004ZV, 10951ZV, and 14016ZV. Healthcare providers and patients with these devices should contact Zavation for further guidance.
The recalled product
- Product
- ZVplasty 10G, 15mm Single Balloon Kit, REF VCF-SBK. For use in Orthopedic / spinal procedures.
- Manufacturer
- Zavation
- Affected units
- 79
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 (11)
- Lot Numbers: 13877ZV
- 13661ZV
- 13388ZV
- 12897ZV
- 12764ZV
- 12542ZV
- 14391ZV
- 14287ZV
- 13004ZV
- 10951ZV
- 14016ZV
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.
See all 71 products in this recall →Related recalls
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