BEUDAMED
    FDA Recall Terminated

    Ascension Orthopedics First Choice Partial Ulnar Head System ("DRUJ System"). Head sizes 14.5 mm, 16.0 mm, 17.5 mm, and 19.0 mm each with stem sizes 4.5 mm, 5.5 mm, or 6.5 mm. The First Choice DRUJ System is intended for replacement of the distal radio-ulnar joint. The Partial Head implant is indicated for replacement of the distal ulnar head for rheumatoid, degenerative, or post-traumatic arthritis

    Recall: Z-1060-2012 · Initiated December 3, 2011

    Recall

    Recall Number
    Z-1060-2012
    Event Number
    60855
    Firm
    Ascension Orthopedics, Inc
    FEI Number
    3002788818
    Product Code
    KXE
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 3, 2011
    Posted
    February 17, 2012
    Terminated
    January 14, 2013
    Address
    8700 Cameron Rd, Ste 100, Austin, TX, 78754-3947

    Description

    Ascension Orthopedics First Choice Partial Ulnar Head System ("DRUJ System"). Head sizes 14.5 mm, 16.0 mm, 17.5 mm, and 19.0 mm each with stem sizes 4.5 mm, 5.5 mm, or 6.5 mm. The First Choice DRUJ System is intended for replacement of the distal radio-ulnar joint. The Partial Head implant is indicated for replacement of the distal ulnar head for rheumatoid, degenerative, or post-traumatic arthritis

    Reason

    A recent review conducted by Ascension Orthopedics revealed that certain modifications were made to the First Choice System and should have been preceded by a submission of a filing with the FDA.

    Action

    The Firm, Ascension Orthopedics, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated December 3, 2011 via FedEx, email or fax to all customers. The letter described the product, problem, and actions to be taken. The customers were instructed to immediately cease any further use of any affected product; remove from their stockrooms until it is shipped back to Ascension Orthopedics; promptly return any affected product to: Ascension Orthopedics, 8700 Cameron Road, Austin, TX 78754, Attn: First Choice DRUJ Recall Administrator, and complete and return the reply form even if you do not have affected product in stock, to Regulatory Affairs Dept. via fax to 512-836-6933. If you have any questions, please do not hesitate to contact customer service at 1-512-836-5001.

    Distribution

    Worldwide distribution.

    Quantity

    1303 units released to customers