BEUDAMED
    FDA Recall Terminated

    GemLock Long Hex Driver, Catalog RHL2.5; Also distributed within the Tapered SwissPlus & SwissPlus Implant Systems Kits, Surgical, Complete, Catalog OPCST; Tapered Screw-Vent Implant System Surgical Kit, Complete, Catalog TSVKIT. Used as a manual delivery tool that engages the Fixture Mount Transfer (FMT) to transport the dental implant from the product packaging to the osteotomy.

    Recall: Z-1115-2015 · Initiated January 22, 2015

    Recall

    Recall Number
    Z-1115-2015
    Event Number
    70304
    Firm
    Zimmer Dental Inc
    FEI Number
    1038806
    Product Code
    NDP
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    January 22, 2015
    Posted
    February 12, 2015
    Terminated
    August 3, 2015
    Address
    1900 Aston Ave, Carlsbad, CA, 92008-7308

    Description

    GemLock Long Hex Driver, Catalog RHL2.5; Also distributed within the Tapered SwissPlus & SwissPlus Implant Systems Kits, Surgical, Complete, Catalog OPCST; Tapered Screw-Vent Implant System Surgical Kit, Complete, Catalog TSVKIT. Used as a manual delivery tool that engages the Fixture Mount Transfer (FMT) to transport the dental implant from the product packaging to the osteotomy.

    Reason

    The Gemlock Long Hex Driver may not fit into the Fixture Mount Transfer (FMT) or the internal hex of the implant.

    Action

    An Urgent Device Recall Notice was sent on 1/22/15 to their domestic and foreign customers who purchased the Gemlock Long Hex Driver. The letter informs the customers of the problems identified, risks, and the actions to be taken. Customers are instructed to review the notice and check their inventory for the affected units. All affected product is to be immediately quarantined and removed from service. Customers are to contact Simmer Dental Customer Service at 1-800-854-7019 to obtain a Return Authorization Number and set up return of the products. Customers should complete the attached Business Reply Form and fax it to (574) 372-4265 or e-mail to [email protected]. Customers with questions are instructed to contact Zimmer Dental Customer Service at (800) 854-7019, Mon-Fri, 7 am-5pm (Pacific). Zimmer Dental is expanding the recall to include 1 additional lot for catalog no.TSVKIT. Zimmer Dental plans to inform an amended customer notification letter to their US and foreign consignees. The letter will go out to customers on 4/20/15 to inform them of the expanded lot.

    Distribution

    Worldwide Distribution -- US, Argentina, Australia, Bulgaria, Canada, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, Egypt, France, Germany, Hong Kong, Hungary, Iran, Israel, Italy, Japan, Lebanon, Lithuania, Malaysia, Mexico, Morocco, Netherlands, Pakistan, Panama, Poland, Romania, Russia, Saudi Arabia, Serbia, Taiwan, Thailand, Tunisia, Turkey, and UAE. Expanded Distribution: Spain

    Quantity

    627 units