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