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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic

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  Class 2 Device Recall Medtronic see related information
Date Initiated by Firm August 31, 2021
Date Posted October 21, 2021
Recall Status1 Open3, Classified
Recall Number Z-0156-2022
Recall Event ID 88586
Product Classification Bur, ear, nose and throat - Product Code EQJ
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 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.
Code Information (1) REF 1882916, GTIN/UPN 20763000041223 - Lot/serial numbers 0217968715, 0218283722, 0218283942, 0218356873, 0218356874, 0218356875, 0218623544, 0219369113, 0219501397, 0219700166, 0220118673, 0220659645, 0220784922, 0220826101, 0220826102, 0221020300, 0221118606, 0221118607, 0221118608, 0221198946, 0221198951, 0221198952, 0221430166, 0221489935, 0221611652, 0221791819, 0221791821; (2) REF 1883514, GTIN/UPN 20763000040967 - Lot/serial numbers 0218283532, 0218791333, 0219215919; (3) REF 1884013, GTIN/UPN 20763000041230 - Lot/serial numbers 0217969616, 0217969617, 0218283944, 0218572177, 0219010745, 0219110914, 0221170726, 0221603993, 0221783424, 0221791809; (4) REF 1884020, GTIN/UPN 20763000040301 - Lot/serial numbers 0219501396, 0220648062, 0220649166, 0220892207, 0221156835, 0221271500; (5) REF 1884032, GTIN/UPN 00763000036140 - Lot/serial numbers 0220057395, 0220057397; (6) REF 1884033, GTIN/UPN 00763000036447 - Lot/serial numbers 0220057389, 0220057390, 0220057392; (7) REF 1882902HRE, GTIN/UPN 00763000036720 - Lot/serial numbers 0217969607, 0218283720, 0218283721, 0219215912, 0219435041, 0221527810, 0221969518; (8) REF 1882905HRE, GTIN/UPN 00763000036782 - Lot/serial numbers 0217968718, 0217968719, 0218283717, 0218283719, 0218356097, 0218790225, 0219215913, 0220177024, 0220659109, 0220659110, 0220878176, 0221091604, 0221091605, 0221118614, 0221258284, 0221527812, 0221611654; (9) REF 1882924HRE, GTIN/UPN 00763000036744 - Lot/serial numbers 0220057236, 0220057237, 0220057238, 0220057239, 0220057241, 0220057242, 0220057243, 0220057244, 0220560777, 0220659671, 0220878169, 0221072336, 0221156836, 0221275006, 0221611653, 0221619324, 0221791822; (10) REF 1882936E, GTIN/UPN 00763000036799 - Lot/serial numbers 0218377217, 0219660525; (11) REF 1882937E, GTIN/UPN 00763000036805 - Lot/serial numbers 0218377221, 0219661147, 0221279640; (12) REF 1882979HRE, GTIN/UPN 00763000033552 - Lot/serial numbers 0217970486, 0217970490, 0218162629, 0218547894; (13) REF 1883080HRE, GTIN/UPN 00763000033989 - Lot/serial numbers 0217261083, 0217261084, 0217261085, 0218354891, 0218421177, 0218790160, 0219036457; (14) REF 1883480HRE, GTIN/UPN 00763000033996 - Lot/serial numbers 0217261083, 0217261084, 0217261085, 0218354891, 0218421177, 0218790160, 0219036457; (15) REF 1883502HRE, GTIN/UPN 00763000036713 - Lot/serial numbers 0217666178, 0217666179, 0218356088, 0218356089, 0218790221, 0219215911, 0219435040, 0220929595, 0221072335, 0221110715, 0221110717, 0221118531, 0221182357, 0221468015; (16) REF 1883506HRE, GTIN/UPN 00763000037376 - Lot/serial numbers 0217666180, 0217666181, 0217667208, 0218356103, 0218790743, 0219728474, 0220070439, 0220118669, 0220158600, 0220484568, 0221119048, 0221258278, 0221468019, 0221611257, 0221611258; (17) REF 1883512HRE, GTIN/UPN 00763000037369 - Lot/serial numbers 0218356098, 0218356099, 0218356100; (18) REF 1883516HRE, GTIN/UPN 00763000037383 - Lot/serial numbers 0217665427, 0217665428, 0217665429, 0217666173, 0217666174, 0217666175, 0217666176, 0217666177, 0218572169, 0219699597, 0219728468, 0219728469, 0219848777, 0219848778, 0219848779, 0219859949, 0220124591, 0220124592, 0220124593, 0220266094, 0220313525, 0220313606, 0220313607, 0220313608, 0220313609, 0220313610, 0220313611, 0220313612, 0220484569, 0220484570, 0220891745, 0220892206, 0221111087, 0221111089, 0221111092, 0221111093, 0221118545, 0221261887, 0221271501, 0221279626, 0221279627, 0221477061, 0221477062, 0221477063, 0221477064, 0221611647, 0221611648, 0221611649, 0221791908, 0221791910, 0221791911; (19) REF 1884005HRE, GTIN/UPN 00763000036737 - Lot/serial numbers 0217968722, 0218161789, 0218161790, 0218356090, 0218790222; (20) REF 1884030HRE, GTIN/UPN 00763000036751 - Lot/serial numbers 0219968104, 0220031839, 0220031841, 0220031842, 0220031843, 0220484572, 0220560783, 0221118618, 0221258283, 0221468017, 0221698794, 0222008093; (21) REF 1884031HRE, GTIN/UPN 00763000036768 - Lot/serial numbers 0219968105, 0220032167, 0220032168, 0220032169, 0220468850, 0220583927, 0220934514, 0221072334, 0221279641, 0221792010, 0222008095; (22) REF 1884033HRE, GTIN/UPN 00763000036775 - Lot/serial numbers 0220057245, 0220057386, 0220057387; (23) REF 1884380HR, GTIN/UPN 20763000038162 - Lot/serial numbers 0217261579, 0217261580, 0217261581, 0217261582, 0217911696, 0217911698, 0217968713, 0218283533, 0218356295, 0218356302, 0218356303, 0218356304, 0218356305, 0218356866, 0218356867, 0218356870, 0218356871, 0218356872, 0218404708, 0218404710, 0218572170, 0218572171, 0218572172, 0218572173, 0218572174, 0218572175, 0218653925, 0218655886, 0218655887, 0218655888, 0218790744, 0218790745, 0218791326, 0218791327, 0218791328, 0218791329, 0218791330, 0218791331, 0218791332, 0219215917, 0219423535, 0219488214, 0219488215, 0219488216, 0219488217, 0219488218, 0219501398, 0219501399, 0219501400, 0219501401, 0219550301, 0219556484, 0219568999, 0219569000, 0219569001, 0219594771, 0219594772, 0219594773, 0219619651, 0219632566, 0219632567, 0219679070, 0219679071, 0219679075, 0219679076, 0219707520, 0219745043, 0219745044, 0219745286, 0219810724, 0219810725, 0219811246, 0219884815, 0219890990, 0220659889, 0220772116, 0220827732, 0220827733, 0220880530, 0220907638, 0220907639, 0220907640, 0220907641, 0220907642, 0220907643, 0220907644, 0221072339, 0221111098, 0221111099, 0221118616, 0221118617, 0221242884, 0221242885, 0221252436, 0221252970, 0221275018, 0221281290, 0221349775, 0221477148, 0221489408, 0221489409, 0221603994, 0221611646, 0221618122, 0221618123, 0221618124, 0221618125, 0221619306, 0221619307, 0221619308, 0221735536, 0221735537, 0221791815, 0221793344, 0221805399, 0221805400, 0221805401, 0221824456, 0221824458, 0222006442, 0222007433, 0222007434, 0222007435, 0222007436; (24) REF 1884380HRE, GTIN/UPN 00763000033910 - Lot/serial numbers 0217663791 0217663792, 0217663793, 0217663794, 0217663795, 0217663796, 0218179447, 0218283718, 0218319250, 0218322548, 0219214785, 0219728473, 0220118670, 0220118671, 0221275019, 0221429981, 0221429982, 0221619338, 0221791811, 0221791812.
Recalling Firm/
Manufacturer		 Medtronic Xomed, Inc.
6743 Southpoint Dr N
Jacksonville FL 32216-6218
For Additional Information Contact Mr. Jimmy Hummel
904-296-9600
Manufacturer Reason
for Recall		 There was an increase in complaints related to tip breaks and wobble/vibration.
FDA Determined
Cause 2		 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 in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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