BEUDAMED
    FDA Recall Terminated

    Synthes Ti Button Plate 7 Holes, Fastener, Fixation, nondegradable, Soft Tissue

    Recall: Z-2138-2016 · Initiated May 31, 2016

    Recall

    Recall Number
    Z-2138-2016
    Event Number
    74418
    Firm
    Synthes (USA) Products LLC
    FEI Number
    3008812560
    Product Code
    MBI
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    May 31, 2016
    Posted
    July 7, 2016
    Terminated
    April 25, 2017
    Address
    1301 Goshen Pkwy, West Chester, PA, 19380-5986

    Description

    Synthes Ti Button Plate 7 Holes, Fastener, Fixation, nondegradable, Soft Tissue

    Reason

    DePuy Synthes is voluntarily initiating a recall due to affected devices being distributed and or labeled with MR Safety information that does not meet the current ASTM standard.

    Action

    Synthes mailed to customers (Hospital Personnel and Sales Consultants) an URGENT FIELD SAFETY NOTIFICATION letter informing them the insert they received, which contained incorrect MR Safety Information, does not meet the current ASTM standards. Customers were asked to review the package insert provided with the notification letter, discard the outdated package insert, complete the attached verification Section (page 3 of this notification) and send a copy of the completed Verification Section by Fax: 844-782-5568 or scan/email: [email protected]. For further questions call (610) 719-6500.

    Distribution

    USA Distribution to the states of : AK,AL,AR,AZ,CA,CH,CO,CT,DC,DE,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,MA,MD,ME,MI,MN,MO,MS,MT,NC,ND,NE,NH,NJ,NM,NV,NY,OH,OK,ON,OR,PA,RI,SC,SD,TN,TX,UT,VA,VT,WA,WI, & WV

    Quantity

    6,255 units