Medtronic Xomed, Inc.: Medical Device Recall in 2021 - (Recall #: Z-0157-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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 1883080EM, Rotatable Fusion Blade, Quadcut 3.0 mm x 13 cm; (2) REF 1883480EM, Rotatable Fusion Blade, Quadcut, 3.4 mm x 13 cm; (3) REF 1884006EM, Rotatable Fusion Blade, RAD 40; (4) REF 1884012EM, Rotatable Fusion Blade, RAD 12; (5) REF 1884080EM, Rotatable Fusion Blade, Tricut, 13 cm; (6) REF 1884380EM, Rotatable Fusion Blade, Quadcut, 4.3 mm x 13 cm.

Product Classification:

Class II

Date Initiated: August 31, 2021

Date Posted: October 27, 2021

Recall Number: Z-0157-2022

Event ID: 88586

Reason for Recall:

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

Status: Ongoing

Product Quantity: 274,991 total devices

Code Information:

(1) REF 1883080EM, GTIN/UPN 00763000034009, Lot/serial numbers: 0217668426, 0217668430, 0217668431, 0218547904, 0219386765, 0219387546, 0221279639, 0221597049; (2) REF 1883480EM, GTIN/UPN 00763000034016, Lot/serial numbers: 0218355352, 0218355353, 0218355354, 0218548106, 0218975242, 0218975243, 0219488206, 0219810719, 0221111103, 0221275012, 0221367934, 0221597050, 0221791924; (3) REF 1884006EM, GTIN/UPN 00763000043254, Lot/serial numbers: 0217260953, 0217260954, 0217260955, 0217260956, 0217260957, 0217260958, 0217260959, 0217969622, 0217969623, 0217969624, 0217969625, 0217970026, 0217970027, 0218162408, 0218162409, 0218282135, 0218282136, 0218282139, 0218311142, 0218311143, 0218311144, 0218311145, 0218356286, 0218356287, 0218356288, 0218356289, 0218356290, 0218356291, 0218356292, 0218975837, 0219215914, 0219215915, 0219215916, 0219715476, 0219715477, 0219811260, 0220659888, 0220804521, 0220826103, 0220878167, 0220878168, 0220929588, 0220996074, 0221199850, 0221367938, 0221477065, 0221477146, 0221586895, 0221618118, 0221791912, 0222046728, 0222046729; (4) REF 1884012EM, GTIN/UPN 00763000043247, Lot/serial numbers: 0217667211, 0217667212, 0217667213, 0217667214, 0217667215, 0217667216, 0218159075, 0218159076, 0218159077, 0218159452, 0218159453, 0218159455, 0218159456, 0218159457, 0218159458, 0218423331, 0218975832, 0219036454, 0219036455, 0219122536, 0219122537, 0221791915; (5) REF 1884080EM, GTIN/UPN 00763000033842, Lot/serial numbers: 0217258057, 0217258058, 0217258059, 0217258060, 0217258061, 0217258062, 0217258063, 0217922715, 0217922716, 0217968723, 0217968724, 0217968725, 0217969086, 0217969087, 0217969088, 0217969089, 0217969090, 0217969091, 0217969092, 0217969093, 0217969094, 0217969095, 0217969096, 0217969098, 0217969099, 0217969100, 0218351460, 0218351462, 0218351463, 0218351464, 0218351465, 0218354786, 0218354787, 0218354788, 0218354789, 0218496725, 0218569925, 0218572166, 0218572167, 0218577805, 0218578866, 0218578867, 0218578868, 0218761931, 0218761932, 0218761933, 0218761934, 0218761935, 0218761936, 0218772873, 0218795848, 0218795849, 0218795850, 0218795851, 0218962903, 0218972892, 0218972893, 0218972894, 0218972895, 0218972896, 0219090839, 0219180699, 0219214780, 0219214781, 0219214782, 0219214783, 0219214784, 0219434676, 0219488207, 0219745076, 0220804698, 0220929480, 0220929481, 0220929482, 0220929483, 0221091281, 0221111100, 0221279635, 0221430167, 0221476225, 0221477046, 0221477047, 0221477048, 0221477049, 0221477051, 0221619326, 0221619330, 0221619331, 0221619332, 0221619333, 0221619334, 0221784366, 0221786297, 0221791918, 0221805157, 0221805158, 0221824122, 0221824123; (6) REF 1884380EM, GTIN/UPN 00763000034023, Lot/serial numbers: 0217258064, 0217258065, 0217260946, 0217260947, 0217260948, 0217260949, 0217260950, 0217260951, 0217260952, 0217262726, 0218179453, 0218348413, 0218355677, 0218355678, 0218355679, 0218355680, 0218355681, 0218355682, 0218355683, 0218355684, 0218355685, 0218422557, 0218422558, 0218496125, 0218497688, 0218497689, 0218497690, 0218572168, 0218683395, 0218683396, 0218683397, 0218683398, 0218795858, 0218795859, 0218795860, 0218975828, 0218975829, 0218975830, 0219215906, 0219215907, 0219215908, 0219215910, 0219653288, 0219653289, 0219802564, 0219834731, 0219848776, 0219854757, 0219890572, 0219890573, 0220484577, 0220484578, 0220659891, 0220659896, 0220703724, 0220703986, 0220703987, 0220703988, 0220703989, 0220878170, 0220878171, 0220878172, 0220878173, 0221072337, 0221110719, 0221110720, 0221118536, 0221118537, 0221118538, 0221118539, 0221181704, 0221182518, 0221271504, 0221278671, 0221279628, 0221279629, 0221305678, 0221319087, 0221468021, 0221477059, 0221477060, 0221489745, 0221489926, 0221611261, 0221616348, 0221619315, 0221619316, 0221619317, 0221619318, 0221792011, 0221805165, 0221805386, 0221805388, 0221824447, 0221824448, 0221824449;

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated