BEUDAMED
    FDA Recall Terminated

    POUCH/CARTON LABEL: ***REF 5023-138***9.5 x 25.5 x 0.4mm***QTY 1***MICRO SAGITTAL BLADE, FINE***STERILE***Rx Only***CONMED LINVATEC, CONMED LINVATEC 11211 CONCEPT BLVD LARGO, FL 33773-4908 USA***Made in USA*** To cut soft tissue or bone

    Recall: Z-1880-2011 · Initiated November 30, 2010

    Recall

    Recall Number
    Z-1880-2011
    Event Number
    58013
    Firm
    Linvatec Corp. dba ConMed Linvatec
    FEI Number
    1017294
    Product Code
    HWE
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    November 30, 2010
    Posted
    April 4, 2011
    Terminated
    November 9, 2011
    Address
    11311 Concept Blvd, Largo, FL, 33773-4908

    Description

    POUCH/CARTON LABEL: ***REF 5023-138***9.5 x 25.5 x 0.4mm***QTY 1***MICRO SAGITTAL BLADE, FINE***STERILE***Rx Only***CONMED LINVATEC, CONMED LINVATEC 11211 CONCEPT BLVD LARGO, FL 33773-4908 USA***Made in USA*** To cut soft tissue or bone

    Reason

    On Nov 30, 2010 ConMed Linvatec, Largo, FL recalled their Micro Sagittal Blade, Fine Lot number 180209, Product Number 5023-138. Some units of Micro Sagittal Blade, Fine from Lot 180209 may have compromised seals in the sterile packaging.

    Action

    Linvatec Corp. dba ConMed sent an Urgent Medical Device Recall Notification letter dated November 30, 2010, by FedEx, email, Fax, etc) to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete the reply form within 30 days of receipt. Immediately check their facility's inventory for the affected product and lot number. If they had any of the product with lot number 180209. Do Not Use. Segregate and return for credit. If the product was transferred to another facility, customers were to complete the REPLY FORM documenting the transfer of the product and fax the form to 727-319-5701. For questions regarding this recall call 727-319-5701 or 800-535-8536.

    Distribution

    Worldwide Distribution - USA including CT, FL, GA, HI, IN, MO, MS, MT, NJ, NY, OH, PA, SC, and TX and the countries of Canada, and South Africa.

    Quantity

    415