BEUDAMED
    FDA Recall Terminated

    00-4309-029-00- Trabecular Metal Reverse Shoulder Liner 36mm, Nonsterile Per surgical technique 97-4309-003-00 Revision 4: "Complete Poly Liner insertion by snapping the appropriate 60 (Standard) or 65 (Retentive) Poly Liner Impactor to the Poly Liner Impactor Handle. Then, place the Poly Liner Impactor on the Poly Liner articular surface and forcefully strike the Poly Liner Handle with a mallet."

    Recall: Z-2214-2012 · Initiated July 18, 2012

    Recall

    Recall Number
    Z-2214-2012
    Event Number
    62540
    Firm
    Zimmer, Inc.
    FEI Number
    1000220733
    Product Code
    KWA
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 18, 2012
    Posted
    August 16, 2012
    Terminated
    April 17, 2014
    Address
    345 E Main St, Warsaw, IN, 46580-2746

    Description

    00-4309-029-00- Trabecular Metal Reverse Shoulder Liner 36mm, Nonsterile Per surgical technique 97-4309-003-00 Revision 4: "Complete Poly Liner insertion by snapping the appropriate 60 (Standard) or 65 (Retentive) Poly Liner Impactor to the Poly Liner Impactor Handle. Then, place the Poly Liner Impactor on the Poly Liner articular surface and forcefully strike the Poly Liner Handle with a mallet."

    Reason

    Lot specific Trabecular Metal (TM) Reverse Shoulder Liner Impactors are being recalled due to reports of alignment peg fractures. All lots of TM Reverse Shoulder Liner Impactors manufactured from 455 stainless steel are being retrieved, as all reported fractured instruments were manufactured with this material. The TM Reverse Shoulder Liner Impactor units that were manufactured with 13-8 stainle

    Action

    Zimmmer sent an Urgent Medical Device Recall letter dated July 18, 2012, to all affected customers. The letter identified the product, the problem, and thea action to be taken by the customer. Customers were instructed to inspect all TM Reverse instrument sets for affected lot(s)(instruments. If affected product was found customers were instructed to immediately place an order to backfill the identified product with Customer Service. If an instrument was was further distributed customers were to provide a copy of the Notice to ensure their customers were aware of the removal. Customers were also instructed to provide a list of all hospitals that currently use the affected product. For questions customers were instructed to call 800-348-2759. For questions regarding this recall call 574-371-1689.

    Distribution

    Worldwide Distribution - USA (nationwide) and internationally to Germany, Belgium, Denmark, Finland, France, Italy, Netherlands, Spain, Sweden, Switzerland, and the United Kingdom.

    Quantity

    75 (51 in USA)