BEUDAMED
    FDA Recall Terminated

    PROFEMUR PLUS CoCr MODULAR NECK, REF: PHAC1254, SIZE LONG, ORIENTATION 8 degree VAR/VAL. 12/14 SLT Taper. Orthopedic hip prosthesis component.

    Recall: Z-2743-2015 · Initiated August 4, 2015

    Recall

    Recall Number
    Z-2743-2015
    Event Number
    71925
    Firm
    MicroPort Orthopedics, Inc.
    FEI Number
    3010536692
    Product Code
    MBL
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    August 4, 2015
    Posted
    September 28, 2015
    Terminated
    August 17, 2018
    Address
    5677 Airline Rd, Arlington, TN, 38002-9501

    Description

    PROFEMUR PLUS CoCr MODULAR NECK, REF: PHAC1254, SIZE LONG, ORIENTATION 8 degree VAR/VAL. 12/14 SLT Taper. Orthopedic hip prosthesis component.

    Reason

    Unexpected rate of postoperative fractures resulting in the need for revision surgery.

    Action

    Micro Port Orthopedics sent a Voluntary Device Product Recall letter dated August 7, 2015, via Fed Ex to all affected customers. The letter identified the product, the problem, and action to be taken by the customer. Customers were instructed to locate and return effected product immediately. Customers with questions were instructed to call 1-866-872-0211. Customers were also asked to return the enclosed form immediately even if they do not have any affected product to return.

    Distribution

    Worldwide Distribution - US (nationwide) and Internationally to AT, BE, CA, CN, CZ, DE, ES, FI, FR, GB, IT, KR, LT, LV, NL, NO, PE, PL, PT, RU, and ST.

    Quantity

    10,489 units