Medtronic Xomed, Inc.: 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.

Recall number

Z-0157-2022

Recalling firm

Medtronic Xomed, Inc.

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 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.

Status

Open, Classified

Initiated

2021-08-31

Posted

2021-10-21

Terminated

not on file

Reason

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

Root cause

Process control

Action

The recalling firm issued letters dated 8/13/2021 on 8/31/2021 via USPS. The letter explained the reason for recall, risk to patient, and the actions to be taken. The consignee was requested to review their inventory of Medtronic blades against the list of affected products enclosed with the letter and to quarantine them. All unused, affected devices are to be returned to Medtronic by completing the Customer Confirmation form and returning it via FAX or email. Once completed, Customer Care will provide return instructions and issue a replacement for the returned product.

Quantity

274,991 total devices

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, 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.

Lot, serial or model codes

(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;

510(k) numbers

["K130608"]

PMA numbers

not on file

Product code

HAW

Firm FEI

1045254

Firm city

Jacksonville

Firm state

FL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy