Kyphx Bone Filler Device recall in Canada: Unintended cement placement
In plain language
This recall involves the Kyphx Bone Filler Device sold in Canada. It's being recalled because a misaligned arrow could cause cement to be placed in an unintended direction during surgery. Stop using the product and follow the return steps in the official notice.
What to do
- Stop using the product immediately.
- Check the model and lot numbers.
- Return the product as instructed by Medtronic.
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Affected products
Kyphx Bone Filler Device
Model: F06A
Lot: WI424428, WI428822, WI435227, WI439940, WI442555, WI446722, WI449819, WI455595, WI459477, WI463434, WI472175, WI472176, WI472177, WI472178, WI474575
Why this matters
Unintended cement placement during surgery
Do I have this product?
This recall only applies to specific products. Follow the steps below to check.
- 1
Check the product name
Make sure your product name matches one of the affected products listed above.
- 2
Check the lot number
Lot numbers identify specific production batches.
Affected lots: WI424428, WI428822, WI435227, WI439940, WI442555, WI446722, WI449819, WI455595, WI459477, WI463434, WI472175, WI472176, WI472177, WI472178, WI474575
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: F06A
If your product matches one or more of the details above, it may be affected by this recall.
If your product does not match these details, it is not affected by this recall.
When in doubt, always check the official notice.
Frequently Asked Questions
Why was this product recalled?
Unintended cement placement during surgery
What should consumers do?
Stop using the product immediately. Check the model and lot numbers. Return the product as instructed by Medtronic.
Where was the product sold?
This product was sold in Canada. For specific retailers or distribution areas, please check the official recall notice linked on this page.
Is there a health risk?
Yes, there may be a health risk. Unintended cement placement during surgery
When was this product recalled?
This product was recalled on January 8, 2018.
Is the Kyphx brand affected by this recall?
Yes, Kyphx products are affected by this recall. This recall involves the Kyphx Bone Filler Device sold in Canada. It's being recalled because a misaligned arrow could cause cement to be placed in an unintended direction during surgery. Stop using the product and follow the return steps in the official notice.