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Recall Observatory FDA recall evidence

Device product

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

Z-1267-2013

April 10, 2013

Class II

Product summary

Firm
Symmetry Medical/SSI
Event
Event 64962
Status
Terminated
Classification
Class II
Quantity
524 boxes of 10
Official record key
device-enforcement:Z-1267-2013

Official wording

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

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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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