KYPHON(R) Directional Bone Filler Device recall
KYPHON(R) Directional Bone Filler Device, Size: 3, REF F04C, Rx Only, STERILE R.
Why was KYPHON(R) Directional Bone Filler Device recalled?
The directional arrow at the proximal end of the instrument may not correctly align with the cutout opening on the distal end of the instrument. Using affected bone void filler may result in the injected cement being placed in a direction unintended by the surgeon.
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?
All Lots
- Product
- KYPHON(R) Directional Bone Filler Device, Size: 3, REF F04C, Rx Only, STERILE R.
- Recalling firm
- Medtronic Sofamor Danek USA Inc
- Quantity
- 17657 units
- Distribution
- worldwide
- Recall date
- June 14, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)