Medtronic sterile single-use blades that are components of the StraightSho ...
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 1882916, RAD 60 Sinus Blade, 11 cm x 2.9 mm;
(2) REF 1883514, RAD 12 Curved Sinus Blade, 11 cm x 3.5 mm;
(3) REF 1884013, Powered Tonsillectomy Blade, 11 cm x 4 mm;
(4) REF 1884020, Tricut Laryngeal Blade, 22.5 cm x 4 mm;
(5) REF 1884032, Tracheal Blade, 37 cm x 4 mm;
(6) REF 1884033, Tracheal Blade, Angle Tip;
(7) REF 1882902HRE, Serrated Blade, 11 cm X 2.9 mm, Rotatable;
(8) REF 1882905HRE, Silver Bullet Blade, 11 cm x 2.9 mm, Rotatable;
(9) REF 1882924HRE, Skimmer Blade, 27 cm x 2.9 mm, Rotatable;
(10) REF 1882936E, Angle-Tip Serrated Blade, 18 cm x 2.9 mm;
(11) REF 1882937E, Angle-Tip Serrated Blade, 22 cm x 2.9 mm;
(12) REF 1882979HRE, Skimmer Blade, 13 cm x 2.9 mm, Rotatable;
(13) REF 1883080HRE, Quadcut Blade, 3.0 mm, Rotatable;
(14) REF 1883480HRE, Quadcut Blade, 3.4 mm, Rotatable;
(15) REF 1883502HRE, Serrated Blade, 11 cm x 3.5 mm, Rotatable;
(16) REF 1883506HRE, RAD 40 Blades, 11 cm x 3.5 mm, Rotatable;
(17) REF 1883512HRE, RAD 12 Blade, 11 cm x 3.5 mm, Rotatable;
(18) REF 1883516HRE, RAD 60 Blade, 11 cm x 3.5 mm, Rotatable;
(19) REF 1884005HRE, Silver Bullet Blade, 11 cm x 4 mm, Rotatable;
(20) REF 1884030HRE, Tricut Airway Blade, Angled Tip, 22 cm x 4 mm, Rotatable;
(21) REF 1884031HRE, Tricut Airway Blade, Angled Tip, 27 cm x 4 mm, Rotatable;
(22) REF 1884033HRE, Tricut Airway Blade, Angled Tip, 37 cm x 4 mm, Rotatable;
(23) REF 1884380HR, Quadcut Blade, 4.3 mm, Rotatable;
(24) REF 1884380HRE, Quadcut Blade, 4.3 mm, Rotatable.
Components:
Recall Date: Aug 31, 2021
Mfg:
Medtronic Xomed, Inc.
Mfg Country:
United States
Recall ID: 88586
Product ID: 189035
Enforcement Date: Oct 27, 2021
Last Published: May 25, 2022
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Emert Number: Z-0156-2022
Emert Status: Updated