PedFuse Bone Probe recall
PedFuse Bone Probe; Part: SI81008 spinal pedicle fixation.
Why was PedFuse Bone Probe recalled?
Bone Probes used to create a pathway in pedicle bone were manufactured and marked to incorrect specifications.
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: 012212-001
- Product
- PedFuse Bone Probe; Part: SI81008 spinal pedicle fixation.
- Recalling firm
- SpineFrontier, Inc.
- Quantity
- 13 devices
- Distribution
- US Distribution: including states of: TX and VA.
- Recall date
- January 15, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)