Devices

Device Recall SC2316, Distal Femoral Augment with Screw

Model / Serial
Part number SC2316-3-5 with lot number 22389-111609. Part number SC2316-4-5 with lot number 22587-111609. Part number SC2316-5-5 with lot number 23214-111609.
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Nationwide Distribution including TX, VA, OK, and PA
Product Description
SC2316, Distal Femoral Augment with Screw || Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems and revision of failed previous reconstructions.
Manufacturer
Stelkast Co
1 Event
- Recall of Device Recall SC2316, Distal Femoral Augment with Screw

Manufacturer

Stelkast Co

Manufacturer Address
Stelkast Co, 200 Hidden Valley Rd, Mcmurray PA 15317-2659
Manufacturer Parent Company (2017)
Stelkast 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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