BEUDAMED
    FDA Enforcement Class II Terminated

    1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 35 mm - Sterile, Rapid Resorbable Fixation System. 1.5 mm Rapid Resorbable Orbital Floor Plate with Bending Template. Intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in pediatric and adult populations.

    Recall: Z-1920-2016 · Reported June 15, 2016

    Enforcement

    Recall Number
    Z-1920-2016
    Event ID
    74053
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Synthes (USA) Products LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 15, 2016
    Initiation Date
    May 2, 2016
    Classification Date
    June 7, 2016
    Termination Date
    December 9, 2016
    Address
    1301 Goshen Pkwy, N/A, West Chester, PA, 19380-5986, United States

    Description

    1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 35 mm - Sterile, Rapid Resorbable Fixation System. 1.5 mm Rapid Resorbable Orbital Floor Plate with Bending Template. Intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in pediatric and adult populations.

    Reason

    Labeling errors. The outer packge label expiration date may exceed the expiration date of the subcomponents.

    Code Info

    Catalog # 851.691.01S, Lot # 6123191, 6913455, 7540885

    Distribution

    Nationwide Distribution to DE, NC, CA, OK, PA, SC, WI, CO, NJ, TX, UT, IL, MO, MI, AL, KS.

    Quantity

    14 units