BEUDAMED
    FDA Recall Terminated

    Persona (TASP) Tibial Articular Surface Provisional Shim, all sizes and Lots Catalog Number: 42-5279-002-00 thru 42-5279-009-04. Product Usage: The Persona TASPs are sterilizable instruments Intended for multiple uses. The TASP components are used to aid the surgeon in assessing the thickness of the articular surface required. The TASP construct is utilized while conducting a trial range of motion. The TASP consists of 3 parts: a TASP bottom, a TASP shim, and a TASP top. The shims come in varying thicknesses to allow trialing for specific Articular Surface implant thicknesses.

    Recall: Z-1052-2015 · Initiated December 11, 2014

    Recall

    Recall Number
    Z-1052-2015
    Event Number
    70240
    Firm
    Zimmer, Inc.
    FEI Number
    1000220733
    Product Code
    OIY
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 11, 2014
    Posted
    February 4, 2015
    Terminated
    October 23, 2015
    Address
    1800 W Center St, Warsaw, IN, 46580-2304

    Description

    Persona (TASP) Tibial Articular Surface Provisional Shim, all sizes and Lots Catalog Number: 42-5279-002-00 thru 42-5279-009-04. Product Usage: The Persona TASPs are sterilizable instruments Intended for multiple uses. The TASP components are used to aid the surgeon in assessing the thickness of the articular surface required. The TASP construct is utilized while conducting a trial range of motion. The TASP consists of 3 parts: a TASP bottom, a TASP shim, and a TASP top. The shims come in varying thicknesses to allow trialing for specific Articular Surface implant thicknesses.

    Reason

    Potential for delay in surgery and/or ball bearings to be left in the wound. Repeated cycles of sonic cleaning can break down the ball bearing retention feature (swage) on the shim. To prevent this, TASP shims must be manually cleaned and inspected per product insert, 87-6203-991-22.

    Action

    Zimmer sent an URGENT MEDICAL DEVICE CORRECTION notifications letter dated December 11, 2014 to affected distributors via electronic mail, and all hospital Risk Managers and distributors with affected inventory via courier. The letter identified the affected product, problem, instructions for responding to the formal recall notification.and actions to be taken. For questions call the customer call center at 1-800-348-2759.

    Distribution

    Worldwide Distribution - USA Nationwide including DC, and PR and the countries of Australia, Austria, Belgium, Canada, Czech Republic, Dominican Republic, France, Germany, India, Iran, Israel, Italy, Japan, Luxembourg, Netherlands, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, United Arab Emirates, and United Kingdom.

    Quantity

    67963