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U.S. Department of Health and Human Services

Enforcement Report - Week of September 11, 2013

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Event Detail

Event ID 65823
Product Type Devices
Status Ongoing
Recalling Firm Stelkast Co
City Mcmurray
State PA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-06-24
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide Distribution including TX, VA, OK, and PA

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. 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. Class II 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. 11 Z-2136-2013