Z-1267-2013 Class II Terminated

Recalled by Symmetry Medical/SSI — Antioch, TN

FDA device recall Z-1267-2013 was initiated by Symmetry Medical/SSI on Apr 10, 2013 and is designated Class II. Reason for recall: There is a possibility that the Collins Radioparent Sternal Blades Nylon may break during use. The recall status is terminated (terminated May 12, 2014). Affected quantity: 524 boxes of 10.

Recall Details

Product Type
Devices
Report Date
May 15, 2013
Initiation Date
Apr 10, 2013
Termination Date
May 12, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
524 boxes of 10

Product Description

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

Reason for Recall

There is a possibility that the Collins Radioparent Sternal Blades Nylon may break during use.

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

Code Information

244576, 244582, 244584, 268916, 268920, 276513, 276514, 296136, 296139, 296141, 296153, 296155, 296156, 296157, 296160