Devices

Device Recall ConFormis

Model / Serial
Serial Numbers (US): 0353281 0355761 0352418 0353880 0354092 0354675 0354821 0355543 0354327 0352462 0354838 0352276 0355506 0355440 0353788 0354652 0349894 0350379 0352905 0354025 0355196 0355405 0355622 0351034 0353474 0353739 0354763 0354158 0355067 0354429 0354764 0353422 0354285 0355646 0355282 0354831 0353993 0355861 0354799 0355519 0353322 0355546 0355319 0355287 0353365 0353987 0355191 0356013 0352467 0354363 0350372 0354462 0355162 0355296 0355070 0354734 0352448 0354116 0353782 0353342 0353040 0355522 0354034 0354476 0354835 0353424 0351578 0353329 0353597 0354408 0354814 0352783 0352940 0352894 0353027 0353492 0352780 0353125 0353929 0353457 0354128 0352830 0354543 0353393 0350374 0353510 0353659 0354329 0354731 0352356 0353996 0353719 0353536 0354611 0353718 0353698 0355577 0355086 0354261 0355369 0352721 0354791 0353907 0354348 0354083 0354913 0353906 0353137 0354217 0355388 0354078 0351433 0353445 0353568 0353678 0355184 0355410 0354357 0354489 0349625 0353344 0354380 0355092 0355190 0355487 0353694 0352789 0355276 0350717 0351645 0351801 0351974 0353200 0353731 0353746 0352301 0353879 0355686 0353555 0352497 0351892 0352645 0353953 0354234 0353091 0353676 0353892 0353525 0353686 0354689 0352675 0352730 0354700 0349501 0354997 0355558 0348201 0354797 0352094 0351889 0353314 0353651 0352070 0353667 0354331 0354949 0354367 0354123 0353835 0354317 0353893 0354935 0353266 0355161 0354833 0353760 0353282 0349733 0352323 0354580 0354704 0349884 0352561 0354060 0353925 0352785 0353414 0354027 0355221 0355347 0355571 0354042 0351810 0351812 0352036 0353837 0353984 0352303 0352740 0354480 0354053 0354093 0356023 0353593 0355366 0354574 0355256 0355218 0353693 0354564 0352800 0353325 0349995 0355358 0353830 0353016 0354368 0354750 0353876 0354153 0353637 0354583 0351816 0350919 0343328 0354482 0355106 0353594 0354469 0355281 0352949 0354302 0355040 0353754 0354253 0355183 0353844 0350226 0350235 0350640 0354839 0353797 0352982 Serial Numbers: OUS 0352548 0350661 0354384 0352569 0354309 0354526 0351329 0354547 0353319 0353211 0355378 0354852 0355036 0354238 0355207 0354568 0353641 0352588 0352589 0355198 0355329 0355402 0355652 0355210 0354009 0354235 0353199 0355666 0355098 0355060 0354320 0354626 0354639 0355052 0354569 0354326 0354655 0352087 0352203 0354562 0355073 0355466 0351749 0353709 0354067 0354070 0352876 0353145 0353521 0353246 0353350 0349077 0349954 0351376 0354011 0354290 0353216 0353710 0352862 0353295 0352778 0353992 0352839 0352716 0353658 0353578 0352407 0353213 0354444 0354386 0353800 0353240 0353291 0354199 0355061 0354623 0355051 0354919 0354068 0353253 0354607 0354187 0354535 0354787 0351890 0353874 0354657 0353776 0352601 0354688 0353982 0354177 0352469 0352470 0354458 0352859 0354824 0354733 0355094 0355211 0349709 0354933 0352084 0354403 0353184
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Distributed Nationwide and in Germany, Switzerland, and UK.
Product Description
ConFormis iTotal CR Knee Replacement System- || iTOTAL CR, Right Knee || Catalog Number: M57250600020 (US) || M5725INT0600020 (OUS)
Manufacturer
ConforMIS, Inc.
1 Event
- Recall of Device Recall ConFormis

Manufacturer

ConforMIS, Inc.

Manufacturer Address
ConforMIS, Inc., 28 Crosby Dr, Bedford MA 01730-1402
Manufacturer Parent Company (2017)
Conformis Inc
Source
USFDA

12 devices with a similar name

Learn more about the data here

Device Recall Conformis iTotal CR G2 Knee Replacement System

Model / Serial
Serial Number: 0340552
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Distributed to IN.
Product Description
Conformis iTotal CR G2 Knee Replacement System || Catalog/Model #: M57250600010 || Intended for use as a total knee replacement in patients with knee joint pain and disability.
Manufacturer
ConforMIS, Inc.

Device Recall ConForMIS

Model / Serial
Serial Numbers (US): 0354697, 0353789, 0354533
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Distributed Nationwide and in Germany, Switzerland, and UK.
Product Description
ConFormis iTotal CR Knee Replacement System- || ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - LEFT || ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - RIGHT || Catalog Number: TCR1111111
Manufacturer
ConforMIS, Inc.

Device Recall ConFormis

Model / Serial
Serial Numbers (US): 0355239 0355108 0355474 0354538 Serial Numbers (OUS): 0353919 0354845 0354849
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
No
Distribution
Distributed Nationwide and in Germany, Switzerland, and UK.
Product Description
ConForMIS iUni Unicondylar Knee Replacement System: || iUNI G2, Left Lateral || Catalog Number: M57220600230 (US) || M5722INT0600230 (OUS)
Manufacturer
ConforMIS, Inc.

Device Recall ConForMis

Model / Serial
Serial Numbers (US): 0353901 0354506 0354220 0355550 0355016 0350789 0354111 0354321 0352939 0353154 0353812 0354828 0354576 0354180 0355588 0355064 0353912 0351237 0351983 0354434 0353374 0351642 0352751 0355557 0353757 0353944 0354218 0353846 0353688 0355110 0352483 0345608 0353771 0353306 3054517 Serial Numbers (OUS): 0348705 0349592 0351522 0351616 0352700 0352750 0352827 0352840 0352999 0353210 0353225 0353263 0353420 0353514 0353515 0353577 0353714 0353791 0353822 0353918 0353921 0354163 0354208 0354284 0354292 0354439 0354507 0354509 0354605 0354771 0354773 0354792 0355178 0355188 0355202 0355227
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
No
Distribution
Distributed Nationwide and in Germany, Switzerland, and UK.
Product Description
ConForMIS Unicondylar Knee Replacement System || iUNI G2, Left Medial || Catalog Number: M57220600210(US) || M5722INT0600210 (OUS)
Manufacturer
ConforMIS, Inc.

Device Recall ConforMIS

Model / Serial
Serial Numbers (US): 0353697 0354749 0349417 0354328 Serial Number (OUS): 0352836 0355233
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
No
Distribution
Distributed Nationwide and in Germany, Switzerland, and UK.
Product Description
ConForMIS iUNI Unicondylar Knee Replacement System || iUNI G2, Right Lateral || Catalog Number: M57220600240 (US) || M5722INT0600240 (OUS)
Manufacturer
ConforMIS, Inc.

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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