Devices

Device Recall iTotal Posterior Stabilized (PS) Knee Replacement System

Model / Serial
Serial numbers: 0398482 & 0399917 Expiration Date: 12/31/2017
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
US Distribution to the states of :CA and TX.
Product Description
Total Knee Replacement , Catalog/Model # TPS-111-1111, UDI: +M572TPS1111111021/$$+31712310398482- and +M572TPS1111111021/$$+31712310399917/ || 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, patellofemoral, or bicompartmental prosthesis.
Manufacturer
ConforMIS, Inc.
1 Event
- Recall of Device Recall iTotal Posterior Stabilized (PS) Knee Replacement System

Manufacturer

ConforMIS, Inc.

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

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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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