PERFORATOR BIT - CRANIUM (2020-10-20)
In plain language
This recall involves PERFORATOR BIT - CRANIUM medical devices sold in Canada. It's being recalled because a visual defect may lead to metal fragments entering a surgical site or delayed disengagement during use. Stop using the product and follow the return steps in the official notice.
What to do
- Stop using the product immediately.
- Check model number 5100-060-001.
- Contact the manufacturer for return instructions.
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Affected products
PERFORATOR BIT - CRANIUM
Model: 5100-060-001
Lot: Multiple lots, contact manufacturer.
Why this matters
Metal fragments entering surgical site or delayed disengagement during use
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: Multiple lots, contact manufacturer.
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 5100-060-001
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?
Metal fragments entering surgical site or delayed disengagement during use
What should consumers do?
Stop using the product immediately. Check model number 5100-060-001. Contact the manufacturer for return 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. Metal fragments entering surgical site or delayed disengagement during use
When was this product recalled?
This product was recalled on November 6, 2020.