Medtronic Xomed, Inc. recalls Medtronic Sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation

Recalled October 27, 2021 · FDA recall Z-0158-2022 · Medtronic Xomed

Hazard

There was an increase in complaints related to tip breaks and wobble/vibration. · FDA Class II

Units

274,991 total devices

Sold at

Worldwide distribution - US Nationwide, including PR. There was also government/military distribution and the countries of Australia, Austria, Bahrain, Belgium, Canada, Chile, Croatia, Czech Republic, Denmark, Dominican Republic, Estonia, Finland, France, Germany, Greece, Guatemala, Hong Kong, Iceland, India, Iran, Ireland, Israel, Italy, Jamaica, Japan, Kenya, Republic of Korea, Kuwait, Latvia, Libya, Luxembourg, Macao, Malaysia, Mauritius, Mongolia, Namibia, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Thailand, Trinidad and Tobago, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Viet Nam.

Description

There was an increase in complaints related to tip breaks and wobble/vibration.

Product

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) REF 40A2500, Nucleus Removal Angled Blade, 25 cm x 4.0 mm; (2) REF 40R2000, Nucleus Removal Set, 20 cm x 4.0 mm; (3) REF 40R2500, Nucleus Removal Set, 25 cm x 4.0 mm; (4) REF 40S2000, Nucleus Removal Straight Blade, 20 cm x 4.0 mm; (5) REF 40S2500, Nucleus Removal Straight Blade, 25 cm x 4.0 mm; (6) REF 45A2000, Nucleus Removal Angled Blade, 20 cm x 4.5 mm; (7) REF 45A2500, Nucleus Removal Angled Blade, 25 cm x 4.5 mm; (8) REF 45R2000, Nucleus Removal Set, 20 cm x 4.5 mm; (9) REF 45R2500, Nucleus Removal Set, 25 cm x 4.5 mm; (10) REF 45S2000, Nucleus Removal Straight Blade, 20 cm x 4.5 mm; (11) REF 45S2500, Nucleus Removal Straight Blade, 25 cm x 4.5 mm.

Manufacturer(s)

Medtronic Xomed, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →