Devices

Device Recall Knee replacement system,

Model / Serial
Lot Number: 670676
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Worldwide distribution: USA including states of: AZ, CA, FL, MI, TX, and UT; and country of: Japan.
Product Description
UC Tibial Insert, Size 4, 12mm, REF 163-3412, Sterile R, Ortho Development, Draper, Utah 84020 || The tibial insert is a device that fits into the tibial tray during knee revision. It provides the base for the metal femoral portion of the system, and moderates the degree of flexion afforded by the procedure.
Manufacturer
Ortho Development Corporation
1 Event
- Recall of Device Recall Knee replacement system,

Manufacturer

Ortho Development Corporation

Manufacturer Address
Ortho Development Corporation, 12187 South Business Park Dr, Draper UT 84020
Manufacturer Parent Company (2017)
Ortho Development Corporation
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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