Evolve Modular Radial Head System recall in Canada: Sterilization risk
In plain language
This recall involves the Evolve Modular Radial Head System - COCR Stem Component sold in Canada. It's being recalled because of incomplete sterilization documentation, meaning the devices may not be sterile. Stop using the product and follow the return steps in the official notice.
What to do
- Stop using the product immediately.
- Check the lot and model numbers.
- Contact Wright Medical Technology Inc. for instructions.
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Affected products
EVOLVE MODULAR RADIAL HEAD SYSTEM - COCR STEM COMPONENT
Model: 496S085
Lot: 1668777
Why this matters
Risk of infection due to non-sterile device
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: 1668777
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 496S085
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?
Risk of infection due to non-sterile device
What should consumers do?
Stop using the product immediately. Check the lot and model numbers. Contact Wright Medical Technology Inc. for instructions.
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. Risk of infection due to non-sterile device
When was this product recalled?
This product was recalled on September 25, 2020.
Is the Evolve brand affected by this recall?
Yes, Evolve products are affected by this recall. This recall involves the Evolve Modular Radial Head System - COCR Stem Component sold in Canada. It's being recalled because of incomplete sterilization documentation, meaning the devices may not be sterile. Stop using the product and follow the return steps in the official notice.