Confidence and Confidence Plus Kit Spinal Cement System (2017-12-18)
In plain language
This recall involves the Confidence and Confidence Plus Kit Spinal Cement System sold in Canada. It's being recalled because the cement may not be visible on X-rays due to incorrect amounts of contrast medium. Stop using the product and follow the return steps in the official notice.
What to do
- Stop using the product immediately.
- Contact Medos International Sarl for more information.
- Return the product as instructed by the manufacturer.
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Affected products
Confidence Plus Kit Spinal Cement System
Model: 2839-10-000
Lot: More than 10 numbers, contact manufacturer.
Confidence Spinal Cement System
Model: 2839-13-000
Lot: More than 10 numbers, contact manufacturer.
Why this matters
X-ray visibility risk
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: More than 10 numbers, contact manufacturer.
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 2839-10-000, 2839-13-000
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?
X-ray visibility risk
What should consumers do?
Stop using the product immediately. Contact Medos International Sarl for more information. Return the product as instructed by the manufacturer.
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. X-ray visibility risk
When was this product recalled?
This product was recalled on January 8, 2018.
Is the Confidence brand affected by this recall?
Yes, Confidence products are affected by this recall. This recall involves the Confidence and Confidence Plus Kit Spinal Cement System sold in Canada. It's being recalled because the cement may not be visible on X-rays due to incorrect amounts of contrast medium. Stop using the product and follow the return steps in the official notice.