BEUDAMED
    FDA Recall Terminated

    Variable Angle Locking Compression Plate/VA-LCP Dorsal Distal Radius Plate, Part Number 02.115.431. Indicated for: Dorsally displaced fractures, Open joint reconstruction, and Corrective osteotomies after distal radius malunion.

    Recall: Z-0956-2013 · Initiated January 11, 2013

    Recall

    Recall Number
    Z-0956-2013
    Event Number
    64194
    Firm
    Synthes USA HQ, Inc.
    FEI Number
    3005180112
    Product Code
    HRS
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    January 11, 2013
    Posted
    March 15, 2013
    Terminated
    August 31, 2015
    Address
    1302 Wrights Ln E, West Chester, PA, 19380-3417

    Description

    Variable Angle Locking Compression Plate/VA-LCP Dorsal Distal Radius Plate, Part Number 02.115.431. Indicated for: Dorsally displaced fractures, Open joint reconstruction, and Corrective osteotomies after distal radius malunion.

    Reason

    It was discovered that one of the VA-LCP Dorsal Distal Radius Plates was incorrectly etched as Part Number 02.115.431 (110 degree) instead of the correct Part Number 02.115.231 (90 degree).

    Action

    The firm initiated their recall of this product on January 11, 2013 by sending an Urgent Notice: Medical Device Recall letter to consignees. The letter identified the affected product and the issue. Synthes requested customers to examine their inventory for the affected product, remove them from use, and return them to Synthes. Additionally, customers were to follow the steps provided in the event that they did or did not have any affected product on hand. Questions should be directed to 610-719-5450 or [email protected].

    Distribution

    Distributed in the states of IN, OH, PA, and TX.

    Quantity

    4