BEUDAMED
    FDA Recall Terminated

    Exactech NOVATION CROWN CUP +5mm LATERALIZED LINER, Use with Crown Cup Only, GXL UHMWPE, SN 0123456, REF 136-32-53. Exactech Hip Systems are indicated for use in surgery for hip replacement.

    Recall: Z-0788-2013 · Initiated November 5, 2012

    Recall

    Recall Number
    Z-0788-2013
    Event Number
    64028
    Firm
    Exactech, Inc.
    FEI Number
    1038671
    Product Code
    LZO
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    November 5, 2012
    Posted
    February 5, 2013
    Terminated
    December 24, 2013
    Address
    2320 NW 66th Ct, Gainesville, FL, 32653-1630

    Description

    Exactech NOVATION CROWN CUP +5mm LATERALIZED LINER, Use with Crown Cup Only, GXL UHMWPE, SN 0123456, REF 136-32-53. Exactech Hip Systems are indicated for use in surgery for hip replacement.

    Reason

    Recall of Novation Crown Cup Connection GXL Neutral Liners Catalog No. (130-32-53) and Novation Crown Cup Connection GXL + 5mm Lateralized Liners Catalog No. (136-32-53). Exactech discovered the device labeling was inadvertently transposed.

    Action

    Exactech, Inc. notified consignees by telephone on 11/05/12 of the affected devices and sent an "IMPORTANT PRODUCT RECALL NOTICE" letter dated 11/06/12. The letter describes the purpose of the recall, the product affected, the problem and actions to be taken by the consignees. A Product Recall Response Form was attached for the consignees to contact the Exactech inventory representative within 5 business days to confirm quantities of product in their inventory and return them to Exactech. Consignees with any questions relating to these devices should call 1-800-392-2832.

    Distribution

    Distributed in the states of TN, FL, VA, WA and NV.

    Quantity

    26 Units