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U.S. Department of Health and Human Services

Enforcement Report - Week of September 11, 2013

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Product Detail

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.
Recall Number Z-2136-2013
Classification Class II
Code Info 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 Distributed Qty 11
Reason For Recall 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.

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 Telephone
Distribution Pattern Nationwide Distribution including TX, VA, OK, and PA