Reported Oct 27, 2021 · Ongoing
Medtronic Sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT…
Medtronic Xomed, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Xomed, Inc. · 6743 Southpoint Dr N · Jacksonville, FL · 32216-6218
Is this the product you have?
11 of 11 products
| Model / number | Product as published |
|---|---|
40A2500 | Medtronic Sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the Midas Rex Microsaw and Triton System with the following product numbers: (1) , Nucleus Removal Angled Blade, 25 cm x 4.0 mm |
40R2000 | (2) , Nucleus Removal Set, 20 cm x 4.0 mm |
40R2500 | (3) , Nucleus Removal Set, 25 cm x 4.0 mm |
40S2000 | (4) , Nucleus Removal Straight Blade, 20 cm x 4.0 mm |
40S2500 | (5) , Nucleus Removal Straight Blade, 25 cm x 4.0 mm |
45A2000 | (6) , Nucleus Removal Angled Blade, 20 cm x 4.5 mm |
45A2500 | (7) , Nucleus Removal Angled Blade, 25 cm x 4.5 mm |
45R2000 | (8) , Nucleus Removal Set, 20 cm x 4.5 mm |
45R2500 | (9) , Nucleus Removal Set, 25 cm x 4.5 mm |
45S2000 | (10) , Nucleus Removal Straight Blade, 20 cm x 4.5 mm |
45S2500 | (11) , Nucleus Removal Straight Blade, 25 cm x 4.5 mm. |
- Amount recalled
- 274,991 total devices
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
There was an increase in complaints related to tip breaks and wobble/vibration.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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