Medical device recall in Canada: MAYFIELD products may cause component fracture
In plain language
This recall involves several MAYFIELD Infinity XR2 Base Units and the MAYFIELD Spine Table Adaptor Radiolucent sold in Canada. They are being recalled because a subcomponent, the standard knob assembly, may fracture or break. Stop using the product and follow the return steps in the official notice.
What to do
- Stop using the product immediately.
- Return the product as instructed by Integra LifeSciences Corporation.
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Affected products
MAYFIELD Infinity XR2 Base Unit
Model: A2079
Lot: Not applicable
MAYFIELD Infinity XR2 Low Profile Base Unit
Model: A2079A
Lot: Not applicable
MAYFIELD Infinity XR2 Base Unit-Extended
Model: A2079E
Lot: Not applicable
MAYFIELD Spine Table Adaptor Radiolucent
Model: A2600R
Lot: Not applicable
Why this matters
Component fracture
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: Not applicable
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: A2079, A2079A, A2079E, A2600R
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?
Component fracture
What should consumers do?
Stop using the product immediately. Return the product as instructed by Integra LifeSciences Corporation.
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. Component fracture
When was this product recalled?
This product was recalled on July 19, 2018.
Is the MAYFIELD brand affected by this recall?
Yes, MAYFIELD products are affected by this recall. This recall involves several MAYFIELD Infinity XR2 Base Units and the MAYFIELD Spine Table Adaptor Radiolucent sold in Canada. They are being recalled because a subcomponent, the standard knob assembly, may fracture or break. Stop using the product and follow the return steps in the official notice.