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Smith & Nephew, Inc. Recall 86927

Description: Bone fixation nail. TRIGEN INTERTAN - Product Usage: indicated for fractures of the femur including simple shaft fractures, comminuted shaft fractures, spiral shaft fractures, long oblique shaft fractures and segmental shaft fracture;

Smith & Nephew, Inc. Recall 86927 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0772-2021
Event ID86927
Event DescriptionBone fixation nail. TRIGEN INTERTAN - Product Usage: indicated for fractures of the femur including simple shaft fractures, comminuted shaft fractures, spiral shaft fractures, long oblique shaft fractures and segmental shaft fracture;
Product TypeDevices
DistributionWorldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, FL, IA, KY, MI, NC, NJ, OH, PA, TN, TX, WA and the countries of AU, CA & GB.
Quantity41 units
Recall ReasonManufacturing packaging error.
Device Classification20210113
Device Code InfoModel #: 71675535 & 71675532 Lot #: 20CM25278 & 20DM01466.
Center Classification Date20210106
Recall Initiation Date20201102
Recalling FirmSmith & Nephew, Inc.
Initial Notification Letter
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