Devices

Device Recall Conformis

  • Model / Serial
    All serial numbers
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - US Nationwide and the country of Germany
  • Product Description
    Conformis iTotal CR-Cruciate Retaining Knee Replacement System || Model Numbers: || M57250600010 iTotal CR, Left Knee || M57250600020 iTotal CR, Right Knee || Product Usage : Usage: || The iTotal CR Knee Replacement System (KRS) is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patello-femoral or bi-compartmental prosthesis.
  • Manufacturer
    Conformis Inc
  • 1 Event

Manufacturer

Conformis Inc
  • Manufacturer Address
    Conformis Inc, 1 North Ave, Suite B, Burlington MA 01803-3305
  • Manufacturer Parent Company (2017)
    Conformis Inc
  • Source
    USFDA

12 devices with a similar name

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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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