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Devices
Device Recall ConForMIS
Model / Serial
Serial Numbers: 0351869
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Distributed Nationwide and in Germany, Switzerland, and UK.
Product Description
ConForMIS iDuo Bicompartmental Knee Replacement System iDUO G2, Left Lateral || Catalog Number: M57230600230
Manufacturer
ConforMIS, Inc.
1 Event
Recall of Device Recall ConForMIS
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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
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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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