BEUDAMED
    FDA Recall Terminated

    Obwegeser Ramus Clamp w/ wide shield, 20 cm, 8", Right. ORAL-MAXILLO-CRANIO-FACIAL SURGERY, Original OBWEGESER Instruments. Walter Lorenz Surgical, Inc., Subsidiary of Biomet Microfixation, Inc. NOTE: None distributed domestically. Cranio-maxillofacial manual instrumentation to be used to aid in the treatment and care of patients, as determined appropriate, by a trained medical professional. The Obwegeser Ramus Clamps are self-retaining clamps, used on the ascending ramus of the mandible with an extension on one of the blades (shields) to aid in retracting the soft tissue of the cheek.

    Recall: Z-0906-2009 · Initiated May 21, 2008

    Recall

    Recall Number
    Z-0906-2009
    Event Number
    50737
    Firm
    Biomet Microfixation, Inc.
    FEI Number
    1032347
    Product Code
    EMG
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    May 21, 2008
    Terminated
    September 11, 2009
    Address
    1520 Tradeport Dr, Jacksonville, FL, 32218-2480

    Description

    Obwegeser Ramus Clamp w/ wide shield, 20 cm, 8", Right. ORAL-MAXILLO-CRANIO-FACIAL SURGERY, Original OBWEGESER Instruments. Walter Lorenz Surgical, Inc., Subsidiary of Biomet Microfixation, Inc. NOTE: None distributed domestically. Cranio-maxillofacial manual instrumentation to be used to aid in the treatment and care of patients, as determined appropriate, by a trained medical professional. The Obwegeser Ramus Clamps are self-retaining clamps, used on the ascending ramus of the mandible with an extension on one of the blades (shields) to aid in retracting the soft tissue of the cheek.

    Reason

    The Biomet Microfixation Obwegeser Ramus Clamp, Wide Right 01-7996 were incorrectly etched as the left part number 01-7997.

    Action

    Customers were contacted by e-mail notification with read receipt. Customers were notified in the e-mail to immediately discontinue use of the recalled product and return the affected items to Biomet Microfixation, Inc. The e-mail also included an Inventory Reconciliation form for customers to complete and return via fax (904-741-1801) to Biomet Microfixation, Inc. For questions related to this notice, please call 1-800-874-7711 or 904-741-4400 extension 448, Monday through Friday, 8 a.m.-4 p.m. Eastern Standard Time (EST).

    Distribution

    International Distribution including countries of Ireland and Japan.

    Quantity

    4