Reported Oct 18, 2023 · Ongoing
MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 or 5.0.1
Mazor Robotics Ltd.
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: Mazor Robotics Ltd · North Industrial Park · Caesarea, N/A · N/A
Is this the product you have?
MAZOR X robotic guidance systemModel TPL0059with software versions 4.2.2 or 5.0.1
- Lot codes and dates
- GTIN 07290109180465
- Serial Numbers
67 of 67 codes
40007707174000800717400081081740008208174000830817400084081740008508174000870817400088081740008909174000900917400091091740009209174000930917400094091740009510174000961017400097101740009810174000991017400100101740010111174001041117400106111740010712174001081217400109121740011012174001111217400112121740011301184001140118400115011840011601184001180118400-26-112016400-27-112016400-29-122016400-30-122016400-31-122016400-36-122016400-38-122016400-44-022017400-47-022017400-48-022017400-50-032017400-51-032017400-53-032017400-54-032017400-55-032017400-56-032017400-59-052017400-60-052017400-61-062017400-63-062017400-64-062017400-65-062017400-67-062017400-68-062017400-69-062017
- Serial Numbers
40012002184001210218400127031840012803184001300518400131051840013205184001330618400136061840013707184001390818400140081840014109184001430918400144091840014509184001470918400148101840015010184001511018400152111840015311184001541118400155111840015611184001571118400160121840016112184001631218400164121840016512184001680119400169011940017101194001740219GTIN 07290109183213
- Serial Numbers
180 of 180 codes
400177021940017802194001790219400180021940018202194001840219400185021940019003194001920419400194041940019604194001970419400198041940019904194002000419400201041940020204194002060519400207051940020805194002090519400210051940021406194002150619400216061940021706194002180619400222071940022308194002240819400225081940022608194002270819400228081940022908194002300819400231091940023309194002340919400235091940023609194002370919400238091940023909194002400919400241101940024210194002441019400245101940024610194002511119400253111940025411194002551119400256111940025911194002611219400262121940026312194002641219
- Serial Numbers
400468032240047003224004710522400479052240048105224004830522400487052240049106224004950622400503072240050807224005130822400514082240051508224005200822400521092240052209224005230922400524092240052509224005290922400533092240053409224005350922400536092240054011224005431122400545112240054711224005481122400550112240055212224005551222400556122240055712224005621222(new 04/11/2024): 40042512214004440222400493062240049806224005491122400596022340060702234006750823
- Amount recalled
- 324 devices
Where it was sold
- Nationwide
Why it was recalled
Software update
This product could cause temporary or reversible health problems — stop using it.
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