CranialMask Tracker recall in Canada: Performance issue
In plain language
This recall involves the CranialMask Tracker medical device sold in Canada. It's being recalled because of a performance issue where the software may generate an error message during surgery. Contact the manufacturer if you require additional information.
What to do
- Contact the manufacturer, Stryker Leibinger Gmbh & Co. Kg, if you require additional information.
- Check the model and lot numbers to see if your product is affected.
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Affected products
CranialMask Tracker
Model: 6000-390-000
Lot: 6000106885, 6000106894, 6000106896
Why this matters
Performance issue
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: 6000106885, 6000106894, 6000106896
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 6000-390-000
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?
Performance issue
What should consumers do?
Contact the manufacturer, Stryker Leibinger Gmbh & Co. Kg, if you require additional information. Check the model and lot numbers to see if your product is affected.
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. Performance issue
When was this product recalled?
This product was recalled on November 27, 2025.
Is the Stryker Leibinger Gmbh & Co. Kg brand affected by this recall?
Yes, Stryker Leibinger Gmbh & Co. Kg products are affected by this recall. This recall involves the CranialMask Tracker medical device sold in Canada. It's being recalled because of a performance issue where the software may generate an error message during surgery. Contact the manufacturer if you require additional information.