Reported Oct 27, 2021 · Ongoing
Medtronic sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT…
Medtronic Xomed, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Xomed, Inc. · 6743 Southpoint Dr N · Jacksonville, FL · 32216-6218
Is this the product you have?
6 of 6 products
| Model / number | Product as published |
|---|---|
1883080EM | 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) , Rotatable Fusion Blade, Quadcut 3.0 mm x 13 cm |
1883480EM | (2) , Rotatable Fusion Blade, Quadcut, 3.4 mm x 13 cm |
1884006EM | (3) , Rotatable Fusion Blade, RAD 40 |
1884012EM | (4) , Rotatable Fusion Blade, RAD 12 |
1884080EM | (5) , Rotatable Fusion Blade, Tricut, 13 cm |
1884380EM | (6) , Rotatable Fusion Blade, Quadcut, 4.3 mm x 13 cm. |
- Lot codes and dates
(1) REF 1883080EMGTIN/UPN 00763000034009
- Lot/serial numbers
02176684260217668430021766843102185479040219386765021938754602212796390221597049(2) REF 1883480EMGTIN/UPN 00763000034016
- Lot/serial numbers
0218355352021835535302183553540218548106021897524202189752430219488206021981071902211111030221275012022136793402215970500221791924(3) REF 1884006EMGTIN/UPN 00763000043254
- Lot/serial numbers
0217260953021726095402172609550217260956021726095702172609580217260959021796962202179696230217969624021796962502179700260217970027021816240802181624090218282135021828213602182821390218311142021831114302183111440218311145021835628602183562870218356288021835628902183562900218356291021835629202189758370219215914021921591502192159160219715476021971547702198112600220659888022080452102208261030220878167022087816802209295880220996074022119985002213679380221477065022147714602215868950221618118022179191202220467280222046729(4) REF 1884012EMGTIN/UPN 00763000043247
- Lot/serial numbers
0217667211021766721202176672130217667214021766721502176672160218159075021815907602181590770218159452021815945302181594550218159456021815945702181594580218423331021897583202190364540219036455021912253602191225370221791915(5) REF 1884080EMGTIN/UPN 00763000033842
- Lot/serial numbers
100 of 100 codes
021725805702172580580217258059021725806002172580610217258062021725806302179227150217922716021796872302179687240217968725021796908602179690870217969088021796908902179690900217969091021796909202179690930217969094021796909502179690960217969098021796909902179691000218351460021835146202183514630218351464021835146502183547860218354787021835478802183547890218496725021856992502185721660218572167021857780502185788660218578867021857886802187619310218761932021876193302187619340218761935021876193602187728730218795848021879584902187958500218795851021896290302189728920218972893021897289402189728950218972896
- Lot/serial numbers
96 of 96 codes
021725806402172580650217260946021726094702172609480217260949021726095002172609510217260952021726272602181794530218348413021835567702183556780218355679021835568002183556810218355682021835568302183556840218355685021842255702184225580218496125021849768802184976890218497690021857216802186833950218683396021868339702186833980218795858021879585902187958600218975828021897582902189758300219215906021921590702192159080219215910021965328802196532890219802564021983473102198487760219854757021989057202198905730220484577022048457802206598910220659896022070372402207039860220703987022070398802207039890220878170
- Amount recalled
- 274,991 total devices
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
There was an increase in complaints related to tip breaks and wobble/vibration.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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