BEUDAMED
    FDA Recall Terminated

    smith&nephew ANTHOLOGY POROUS HIGH OFFSET STEM, 12/14 TAPER, 7H SIZE, 32 MM x 112 MM, REF 71356107 Hip prosthesis.

    Recall: Z-1921-2018 · Initiated May 2, 2018

    Recall

    Recall Number
    Z-1921-2018
    Event Number
    80050
    Firm
    Smith & Nephew, Inc.
    FEI Number
    1020279
    Product Code
    JDI
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 2, 2018
    Posted
    May 9, 2018
    Terminated
    September 1, 2020
    Address
    1450 E Brooks Rd, Memphis, TN, 38116-1804

    Description

    smith&nephew ANTHOLOGY POROUS HIGH OFFSET STEM, 12/14 TAPER, 7H SIZE, 32 MM x 112 MM, REF 71356107 Hip prosthesis.

    Reason

    Three lots of Anthology HO Porous size 7 stems were manufactured with an undersized taper length. The device taper length was incorrectly manufactured as 0.393mm opposed to 0.442 mm.

    Action

    The firm initiated the recall by letter on 05/02/2018. Consignees are asked to inspect inventory, locate and quarantine affected, unused devices. Affected product will be returned to Smith & Nephew. All consignees are asked to complete the Response Form, even if they do not have product to return. Distributors were directed to notify their customers of the field action and ensure that these actions are carried out. For further questions, please call (978) 749-1440

    Distribution

    US nationwide distribution.

    Quantity

    13 units