Device 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.
Z-2136-2013
Product summary
- Firm
- Stelkast Co
- Event
- Event 65823
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11
- Official record key
device-enforcement:Z-2136-2013
Official wording
Reason: 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.
Code information: 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.
Distribution pattern: Nationwide Distribution including TX, VA, OK, and PA
Derived failure modes
-
Sterility assurance
breach of sterility