BEUDAMED
    FDA Recall Terminated

    BIOMET MICROFIXATION "1.5MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, QTY 1, 1.5 X 4MM TITANIUM. REF 91-1504 1 COUNT and REF 95-1504 - 5 PACK. BIOMET MICROFIXATION 1520 TRADEPORT DRIVE, JACKSONVILLE, FL 32218 USA, WWW.BIOMETMICROFIXATION.COM. Intended to aid in the alignment and stabilization of bone in the oral cranio-maxillofacial skeletal system.

    Recall: Z-2206-2010 · Initiated March 17, 2010

    Recall

    Recall Number
    Z-2206-2010
    Event Number
    54370
    Firm
    Biomet Microfixation, Inc.
    FEI Number
    1032347
    Product Code
    DZL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 17, 2010
    Posted
    August 11, 2010
    Terminated
    August 11, 2010
    Address
    1520 Tradeport Dr, Jacksonville, FL, 32218-2480

    Description

    BIOMET MICROFIXATION "1.5MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, QTY 1, 1.5 X 4MM TITANIUM. REF 91-1504 1 COUNT and REF 95-1504 - 5 PACK. BIOMET MICROFIXATION 1520 TRADEPORT DRIVE, JACKSONVILLE, FL 32218 USA, WWW.BIOMETMICROFIXATION.COM. Intended to aid in the alignment and stabilization of bone in the oral cranio-maxillofacial skeletal system.

    Reason

    Biomet Microfixation has received a complaint from a customer who reports finding a 3.5mm length screw in one 5 pack of 4mm length screws.

    Action

    Biomet Microfixation is recalling their 1.5x4mm HT X-drive Screws Lot Number 148530 after receiving a customer reported finding one 3.5MM screw in a package labeled as containing 4.0MM screws. Lot 148530 was packaged into one count packages 91-1504 and 5 count packages 95-1504. The 1 and 5 count packages were distributed between 12/10/2009 and 02/01/2010. Beginning on 03/17/2010 customers identified as receiving Lot 148530 HT X-drive Screws were notified of the recall by a combination of an Urgent Medical Device Recall Notice letter, e-mail, fax and telephone calls. Customers were instructed to inspect their inventory and to return any affected products. They were instructed to complete the attached Inventory Reconciliation sheet and to fax it to Biomet Microfixation. Customers were also instructed to contact any customers to whom they may have further distributed the product. Questions should be directed to Christy Cain at 1-800-874-7711 or 904-741-4400, ext. 468.

    Distribution

    Worldwide Distribution -- USA, including states of FL, GA, IN, LA, MD, MI, MO, NC, NY, OK, TX, and VA and countries of Philippines, Japan, Brazil, and Canada.

    Quantity

    1247 screws