BEUDAMED
    FDA Recall Terminated

    7.5mm Ti Solid Humeral Nail 250 mm Sterile Catalog number 462.725S Synthes Titanium Solid Humeral Nail System is intended for intramedullary fixation of a variety of humeral fractures using either an antegrade or retrograde approach. The indications for the Titanium Solid Humeral Nail System includes: diaphyseal fractures of the humeral shaft, fractures of the proximal humerus, proximal humeral fractures with diaphyseal extension, and impending pathological fractures.

    Recall: Z-1549-2010 · Initiated February 25, 2010

    Recall

    Recall Number
    Z-1549-2010
    Event Number
    55147
    Firm
    Synthes USA (HQ), Inc.
    FEI Number
    3005180112
    Product Code
    JDS
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 25, 2010
    Posted
    May 7, 2010
    Terminated
    October 20, 2014
    Address
    1302 Wrights Ln E, West Chester, PA, 19380-3417

    Description

    7.5mm Ti Solid Humeral Nail 250 mm Sterile Catalog number 462.725S Synthes Titanium Solid Humeral Nail System is intended for intramedullary fixation of a variety of humeral fractures using either an antegrade or retrograde approach. The indications for the Titanium Solid Humeral Nail System includes: diaphyseal fractures of the humeral shaft, fractures of the proximal humerus, proximal humeral fractures with diaphyseal extension, and impending pathological fractures.

    Reason

    potential compatibility issue

    Action

    The recalling firm, Synthes, issued an "URGENT: MEDICAL DEVICE RECALL" letter dated February 25, 2010, return receipt requested, to all customers. The letter describes the product, problem and action to be taken by customers. The customers were instructed to immediately cease use of the products, examine their inventory for the part/lot combinations and remove the recalled devices from their shelves, call Synthes at 1-800-479-6329 to obtain a Return Authorization Number and return the recalled product with the letter; however, if the customers do not have the identified product , they should complete the attached verification section and return document to Synthes by Fax at 610-719-5120 or scan/email at [email protected]. If you should have any questions, please call 800-620-7025 x 5452 or 610-719-5452 or contact your Synthes Trauma Sales Consultant.

    Distribution

    Nationwide distribution: LA, MA, ME, NC, PA and VA.

    Quantity

    5 units