FDA-Device2013-09-11Class II
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.
Stelkast Co
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.
Sold states
Nationwide Distribution including TX, VA, OK, and PA
Affected count
11
Manufactured in
200 Hidden Valley Rd, N/A, Mcmurray, PA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2136-2013Don't want to check this manually?
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