FDA Enforcement Class II Ongoing

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: Z-0157-2022 · Reported October 27, 2021

Enforcement

Recall Number: Z-0157-2022
Event ID: 88586
Classification: Class II
Status: Ongoing
Product Type: Devices
Firm: Medtronic Xomed, Inc.
Voluntary / Mandated: Voluntary: Firm initiated
Initial Notification: Letter
Report Date: October 27, 2021
Initiation Date: August 31, 2021
Classification Date: October 21, 2021
Address: 6743 Southpoint Dr N, N/A, Jacksonville, FL, 32216-6218, United States

Description

Reason

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

Code Info

(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

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.

Quantity

274,991 total devices