Health product recall

Rotatable Fusion Blades

Last updated

Summary

Product
Rotatable Fusion Blades
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

Rotatable Fusion Blades

More than 10 numbers, contact manufacturer.

1884080EM
1883480EM
1884006EM
1884012EM
1884380EM
1883080EM

Issue

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

Additional information

Details
Original published date: 2022-08-11
Alert / recall type
Health product recall
Category
Health product - Medical device - General and plastic surgery
Companies

Medtronic Navigation, Inc.

826 Coal Creek Circle, Louisville, Colorado, United States, 80027

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-64447