No image published for this recall
Rotatable fusion blades
Official notice
1 Sept 2021
Last checked
1 Sept 2021
An official Health Canada notice concerns Rotatable fusion blades. Medtronic is voluntarily recalling specific lot numbers of sterile blade single-use accessories. Navigation blades are being used to aid in accuracy during the procedure, and if they wobble, that accuracy and precision is diminished. Medtronic has received complaints related to tip breaks and wobble/vibration in this subset of devices. Tip breaks or detachment of fragments may cause harm to the patient, cause lack of oxygenation or foreign body reaction if the fragment were to migrate into the patient's airway or be irretrievable. There is also a chance that the tip may impact critical structures such as nerves and arteries. Blade wobble or vibration may also lead to permanent damage if it causes the blade to impact critical structures. Recall start date: August 16, 2021 Published 2021-09-01.
What to do now
Contact the manufacturer if you require additional information.
Recall number
64447
Official notice
2021-09-01
The hazard
The hazard
Medtronic is voluntarily recalling specific lot numbers of sterile blade single-use accessories. Navigation blades are being used to aid in accuracy during the procedure, and if they wobble, that accuracy and precision is diminished. Medtronic has received complaints related to tip breaks and wobble/vibration in this subset of devices. Tip breaks or detachment of fragments may cause harm to the patient, cause lack of oxygenation or foreign body reaction if the fragment were to migrate into the patient's airway or be irretrievable. There is also a chance that the tip may impact critical structures such as nerves and arteries. Blade wobble or vibration may also lead to permanent damage if it causes the blade to impact critical structures. Recall start date: August 16, 2021
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
Recall Numbers
Checked manually this time?
The app alerts you when a new official recall is published — no searching, no checking back.
Turn on recall alertsAffected products
Affected products
Product 1
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Medtronic Navigation, Rotatable Fusion Blades.
Source & status
Source & status
Source
Tier
Category
Classification
App estimate
Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
View full official noticeWeekly recall digest
Get next week's recalls before you need them.
One email every Monday — official-source recalls for your country, and nothing else. Unsubscribe from any email.
The digest is the slow lane — one email a week. For instant, severity-gated alerts the moment a notice is published, get the app.
This recall was published 1 Sept 2021. The next one won't wait for you to search.
RecallScope watches official sources for the brands and VINs you follow, and alerts you the moment a new notice is published.
