Devices

Device Recall ConFormis

Model / Serial
Serial Numbers (US): Left: 0353417 0353616 0354944 0353554 0348951 0354052 0351267 0352723 0353063 0353116 0352223 0351354 0353685 0354118 0354573 0351678 0354306 0355213 0354531 0352895 0353969 0354670 0352804 0353375 0353584 0353955 0353394 0354457 0354251 0354470 0353392 0351881 0353596 0352702 0354028 0354049 0352925 0354005 0354115 0354863 0352181 0354089 0353451 0354720 0352945 0353262 0353662 0353269 Right:: 0353557 0354179 0350279 0355149 0353833 0353430 0353480 0353628 0354373 0352045 0353346 0350509 0352556 0353120 0353287 0353535 0354487 0354691 0351677 0354706 0353997 0354119 0353421 0353585 0353580 0353617 0354393 0354940 0353390 0353634 0353720 0354226 0353080 0353372 0353096 0354048 0354050 0354054 0354947 0353806 0354257 0354478 0354938 0355240 0354063 0352352 0353728 0353725 0354430 0353278 0353433 0353810 0352946 0353664 0353665 0354247 Serial Numbers: (OUS) iTOTAL PSIPOLYIMPLANT KIT LEFT 0352550 ITOTAL PSIPOLYIMPLANT KIT RIGHT 0353042 ITOTAL PSIPOLYIMPLANT KIT RIGHT 0353150 ITOTAL PSIPOLYIMPLANT KIT RIGHT 0353250 ITOTAL PSIPOLYIMPLANT KIT LEFT 0353544
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Distributed Nationwide and in Germany, Switzerland, and UK.
Product Description
ConFormis iTotal Posterior Stabilized Knee Replacement System- || ITOTAL PS-IPOLY- IMPLANT KIT-LEFT and || ITOTAL PS-IPOLY-IMPLANT KIT-RIGHT || Catalog Number:TPS1111111
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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