ZVplasty recall
ZVplasty 10G, 15mm Single Balloon Kit, REF VCF-SBK. For use in Orthopedic / spinal procedures.
Why was ZVplasty recalled?
Products distributed as sterile may not have been adequately sterilized
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Numbers: 13877ZV, 13661ZV, 13388ZV, 12897ZV, 12764ZV, 12542ZV, 14391ZV, 14287ZV, 13004ZV, 10951ZV, 14016ZV
- Product
- ZVplasty 10G, 15mm Single Balloon Kit, REF VCF-SBK. For use in Orthopedic / spinal procedures.
- Recalling firm
- Zavation
- Quantity
- 79 units
- Distribution
- US nationwide distribution.
- Recall date
- June 9, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)