ZVplasty Direct Bipedicular Bone Access Kit with Drill recall
ZVplasty Direct Bipedicular Bone Access Kit with Drill, 10 Gauge, VCF-DDBAK. For use in Orthopedic / spinal procedures.
Why was ZVplasty Direct Bipedicular Bone Access Kit with Drill 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: 20071860, 2004988, 19113040, 20071775
- Product
- ZVplasty Direct Bipedicular Bone Access Kit with Drill, 10 Gauge, VCF-DDBAK. For use in Orthopedic / spinal procedures.
- Recalling firm
- Zavation
- Distribution
- US nationwide distribution.
- Recall date
- June 9, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)