BEUDAMED
    FDA Recall Terminated

    Part #313.221, 1.5mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341033, 4589566, 4703774, 4363781, 4589567, 4793575, 4904305, 4427700,4589568, 4830581, 4532370, 4673943, 4871657, mfg. 2/12/2002-5/23/2005 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.

    Recall: Z-2196-2016 · Initiated May 31, 2016

    Recall

    Recall Number
    Z-2196-2016
    Event Number
    74416
    Firm
    Synthes (USA) Products LLC
    FEI Number
    3008812560
    Product Code
    HWE
    Status
    Terminated
    Root Cause
    Labeling False and Misleading
    Initiated
    May 31, 2016
    Posted
    July 12, 2016
    Terminated
    February 2, 2017
    Address
    1301 Goshen Pkwy, West Chester, PA, 19380-5986

    Description

    Part #313.221, 1.5mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341033, 4589566, 4703774, 4363781, 4589567, 4793575, 4904305, 4427700,4589568, 4830581, 4532370, 4673943, 4871657, mfg. 2/12/2002-5/23/2005 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.

    Reason

    DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed, etched and or labeled with MR Safety information not meeting the current ASTM standard.

    Action

    DePuy Synthes mailed an URGENT MEDICAL DEVICE FIELD SAFETY NOTIFICATION letter to their customers (Hospital Personnel, including Imaging Department Personnel and DePuy Synthes Colleague) to inform them of the recall and actions to take. The letter identified the affected, problem and actions to be taken. The letter instructed customers not to use the affected Instruments which are labeled or etched MR Safe and MR Conditional during MRI scans. Customers were asked to review the information contained in the Field Safety Notification letter and complete the Verification Section located on page 3 of this notification. For questions call 610-719-5450 or contact your DePuy Synthes Sales Consultant.

    Distribution

    US Nationwide Distribution in the states of: AR,CA,CO,CT,DC,ID,IL,KY,LA,MA,MD,MN,MO,MS,MT,NY,PA and TX.

    Quantity

    383 units