BEUDAMED
    FDA Recall Terminated

    Zimmer Trabecular Metal Total Ankle Talar Component Right Sizes 1-6 Total ankle arthroplasty is intended to provide a patient with limited mobility by restoring alignment, reducing pain and preserving the flexion/extension movement within the ankle joint.The Zimmer Trabecular Metal Total Ankle is indicated as a total ankle replacement in primary or revision surgery for patients with: " Rheumatoid arthritis. " Post-traumatic arthritis. " Degenerative arthritis. This device is intended for cemented use only.

    Recall: Z-0476-2014 · Initiated November 12, 2013

    Recall

    Recall Number
    Z-0476-2014
    Event Number
    66717
    Firm
    Zimmer, Inc.
    FEI Number
    1000220733
    Product Code
    HSN
    Status
    Terminated
    Root Cause
    Manufacturing material removal
    Initiated
    November 12, 2013
    Posted
    December 10, 2013
    Terminated
    October 15, 2014
    Address
    345 E Main St, Warsaw, IN, 46580-2746

    Description

    Zimmer Trabecular Metal Total Ankle Talar Component Right Sizes 1-6 Total ankle arthroplasty is intended to provide a patient with limited mobility by restoring alignment, reducing pain and preserving the flexion/extension movement within the ankle joint.The Zimmer Trabecular Metal Total Ankle is indicated as a total ankle replacement in primary or revision surgery for patients with: " Rheumatoid arthritis. " Post-traumatic arthritis. " Degenerative arthritis. This device is intended for cemented use only.

    Reason

    As part of routine manufacturing process monitoring by Zimmer, it was discovered that the Tibial Base and Talar Components from the Total Ankle system have the potential of containing elevated levels of manufacturing materials residue on the implants. The specific material was found to be mass media utilized during the manufacturing process to provide the uniform surface finish. This mass media

    Action

    Zimmer sent an URGENT MEDICAL DEVICE RECALL notification letter dated November 12, 2013 to all consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to locate and remove the affected product from their inventory and notify their Zimmer representataive. The Zimmer representative will remove the recalled product from their facility. For patients that previously had the affected product implanted, consignees were instructed to continue their operative follow up routine. Consignees with questions were instructed to call 1-877-946-2761. For questions regarding this recall call 800-613-6131.

    Distribution

    Worldwide Distribution - USA (nationwide) and Internationally to Australia, Canada, China, Finland, Germany, and Italy.

    Quantity

    265 units (US) 114 units (outside US)