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U.S. Department of Health and Human Services

Enforcement Report - Week of May 15, 2013

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Event Detail

Event ID 64962
Product Type Devices
Status Ongoing
Recalling Firm Symmetry Medical/SSI
City Antioch
State TN
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-04-10
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Worldwide Distribution - USA including CA, MS, FL, PA, TN, CO, IL, TX, OH, MI, MA, IL and internationally to Belgium, Canada, Germany, UK

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Codman(R) Collins Radioparent Sternal Blade Nylon,4 3/4" (121 mm) long, 3" (76 mm) wide, 1 1/2" (38 mm) deep, REF 50-8081 sternum retractor 244576, 244582, 244584, 268916, 268920, 276513, 276514, 296136, 296139, 296141, 296153, 296155, 296156, 296157, 296160 Class II There is a possibility that the Collins Radioparent Sternal Blades Nylon may break during use. 524 boxes of 10 Z-1267-2013
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