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Product Description
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Recall Class
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FDA Recall Posting Date
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Recalling Firm
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Z-0147-2016 - ConFormis iTotal Posterior Stabilized Knee Replacement System-
ITOTAL PS-IPOLY- IMPLANT KIT-LEFT and
ITOTAL PS-IPOLY-IMPLANT KIT-RIGHT
Catalog Number:TPS1111111
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2
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10/21/2015
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ConforMIS, Inc.
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Z-0146-2016 - ConFormis iTotal CR Knee Replacement System-
iTOTAL CR, Right Knee
Catalog Number: M57250600020 (US)
M5725INT0600020 (OUS)
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2
|
10/21/2015
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ConforMIS, Inc.
|
Z-0144-2016 - ConFormis iTotal CR Knee Replacement System-
ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - LEFT
ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - RIGHT
Catalog Number: TCR1111111
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2
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10/21/2015
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ConforMIS, Inc.
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Z-0148-2016 - ConFormis iDUO G2, Right Lateral
Catalog Number: M5723INT0600240 (US)
M5723INT0600240 (OUS)
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2
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10/21/2015
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ConforMIS, Inc.
|
Z-0138-2016 - ConForMIS iUni Unicondylar Knee Replacement System:
iUNI G2, Left Lateral
Catalog Number: M57220600230 (US)
M5722INT0600230 (OUS)
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2
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10/21/2015
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ConforMIS, Inc.
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Z-0141-2016 - ConForMIS iUni Unicondylar Knee Replacement System-
iUNI G2, Right Medial
Catalog Number:M57220600220 (US)
M5722INT0600220 (OUS)
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2
|
10/21/2015
|
ConforMIS, Inc.
|
Z-0140-2016 - ConForMIS iUNI Unicondylar Knee Replacement System
iUNI G2, Right Lateral
Catalog Number: M57220600240 (US)
M5722INT0600240 (OUS)
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2
|
10/21/2015
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ConforMIS, Inc.
|
Z-0145-2016 - ConForMIS iTotal CR (Cruciate Retaining) Knee Replacement System-iTOTAL CR, Left Knee
Catalog Number: M57250600010 (US)
M5725INT0600010 (OUS)
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2
|
10/21/2015
|
ConforMIS, Inc.
|
Z-0143-2016 - ConForMIS iDuo Knee Bicompartmental Knee Replacement System , iDUO G2, Right Medial
Catalog Number: M57230600220 (US)
M5723INT0600220 (OUS)
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2
|
10/21/2015
|
ConforMIS, Inc.
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Z-0142-2016 - ConForMIS iDuo Bicompartmental Knee Replacement System iDUO G2, Left Lateral
Catalog Number: M57230600230
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2
|
10/21/2015
|
ConforMIS, Inc.
|