BEUDAMED
    FDA Recall Terminated

    ST ULTRAPOWER DIAMOND WHEEL (RED) 25.4mm, Catalog Number 00702109200, STERILE, Single-use. Made is USA. ST ULTRAPOWER Diamond Wheel/MDS M-51, (MUSTARD) 25.4 mm For Use with Low or Medium Speed Drills Only, Catalog Number 00702129200, STERILE. Made in USA. ST ULTRAPOWER Diamond Wheel/MDS AM-51, (LIME) 25.4mm For Use with Low or Medium Speed Drills Only, Catalog Number 00702139200, STERILE. Made in USA. ST ULTRAPOWER BUR Diamond Wheel/MDS TU-51 (TEAL) 25.4mm For Use with Low or Medium Speed Drills Only, Catalog Number 00702149200, STERILE. Made is USA. Single use devices. CONMED LINVATEC 11311 Concept Blvd Largo, FL 33773-4908 Surgical instrument motors and accessories are AC-powered, or air-powered devices intended for the use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, a chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver and saw blade.

    Recall: Z-2041-2009 · Initiated July 31, 2009

    Recall

    Recall Number
    Z-2041-2009
    Event Number
    52804
    Firm
    Linvatec Corp. dba ConMed Linvatec
    FEI Number
    1017294
    Product Code
    HTT
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    July 31, 2009
    Posted
    September 8, 2009
    Terminated
    May 11, 2010
    Address
    11311 Concept Blvd, Largo, FL, 33773-4908

    Description

    ST ULTRAPOWER DIAMOND WHEEL (RED) 25.4mm, Catalog Number 00702109200, STERILE, Single-use. Made is USA. ST ULTRAPOWER Diamond Wheel/MDS M-51, (MUSTARD) 25.4 mm For Use with Low or Medium Speed Drills Only, Catalog Number 00702129200, STERILE. Made in USA. ST ULTRAPOWER Diamond Wheel/MDS AM-51, (LIME) 25.4mm For Use with Low or Medium Speed Drills Only, Catalog Number 00702139200, STERILE. Made in USA. ST ULTRAPOWER BUR Diamond Wheel/MDS TU-51 (TEAL) 25.4mm For Use with Low or Medium Speed Drills Only, Catalog Number 00702149200, STERILE. Made is USA. Single use devices. CONMED LINVATEC 11311 Concept Blvd Largo, FL 33773-4908 Surgical instrument motors and accessories are AC-powered, or air-powered devices intended for the use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, a chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver and saw blade.

    Reason

    ConMed Linvatec is recalling Ultrapower Bur, Diamond Wheel for possibility of a packaging breach in the sterile barrier.

    Action

    Firm notified international and domestic consignees by an Urgent Medical Device Recall letter on July 31, 2009. Customers were asked to check their inventory; complete, sign, and return the enclosed Reply Form; and return the devices for credit. Questions should be directed to Customer Service at 1-800-237-0169.

    Distribution

    Worldwide Distribution

    Quantity

    2502