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
Check against the official notice below — it lists the full affected range.
Medtronic Xomed, Inc. is recalling sterile single-use blades that are components of the StraightShot M Series Handpiece, Fusion ENT Navigation Software, Midas Rex Microsaw, and Triton System due to an increase in complaints of tip breaks and wobble/vibration. The recall affects approximately 274,991 devices distributed worldwide, including throughout the United States, Puerto Rico, and numerous countries across Europe, Asia, the Middle East, Africa, and the Americas.
The recall involves eleven different blade reference numbers with specific lot and serial numbers. The source document does not specify what remedy or action affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
There was an increase in complaints related to tip breaks and wobble/vibration.
Reason for recall: There was an increase in complaints related to tip breaks and wobble/vibration. Distribution: 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, L Quantity: 274,991 total devices Lot/code info: (1) REF 40A2500, GTIN/UPN 00763000033835, Lot/serial number 0220002825; (2) REF 40R2000, GTIN/UPN 00763000033866, Lot/serial number 0218179458; (3) REF 40R2500, GTIN/UPN 00763000033798, Lot/serial number 0218299192; (4) REF 40S2000, GTIN/UPN 00763000033873, Lot/serial number 0218179459; (5) REF 40S2500, GTIN/UPN 00763000043193, Lot/serial number 0220226674; (6) REF 45A2000, GTIN/UPN 00763000033880, Lot/serial number 0220443669; (7) REF 45A2500, GTIN/UPN 00763000043223, Lot/serial number 0218323602; (8) REF 45R2000, GTIN/UPN 00763000033897, Lot/serial numbers 0218284087, 0218292178, 0218973633; (9) REF 45R2500, GTIN/UPN 00763000033811, Lot/serial number 0218297618; (10) REF 45S2000, GTIN/UPN 00763000033903, Lot/serial number 0218299193; (11) REF 45S2500, GTIN/UPN 00763000043216, Lot/serial number 0218297619.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.