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Stelkast Co recalls SC2316, Distal Femoral Augment with Screw Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid art
Recalled September 11, 2013 · FDA recall Z-2136-2013 · Stelkast
Hazard
The firm became aware of an incident relating to a breach of sterility in the sterility barrier packaging of SC2316, Distal Femoral Augment with Screw. · FDA Class II
Units
11
Sold at
Nationwide Distribution including TX, VA, OK, and PA
Description
The firm became aware of an incident relating to a breach of sterility in the sterility barrier packaging of SC2316, Distal Femoral Augment with Screw.
Product
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(s)
Stelkast Co
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →