BEUDAMED
    FDA Enforcement Class II 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 · Reported February 11, 2015

    Enforcement

    Recall Number
    Z-1052-2015
    Event ID
    70240
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 11, 2015
    Initiation Date
    December 11, 2014
    Classification Date
    February 4, 2015
    Termination Date
    October 23, 2015
    Address
    1800 W Center St, N/A, Warsaw, IN, 46580-2304, United States

    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.

    Code Info

    Persona (TASP) Tibial Articular Surface Provisional Shim, all sizes and Lots Catalog Number: 42-5279-002-00 thru 42-5279-009-04: 42-5279-002-00 All Lots Persona Constrained TASP (Tibial A/S Prov.) Shim, CD, 10mm; 42-5279-002-02 All Lots Persona Constrained TASP (Tibial A/S Prov.) Shim, CD, 12mm; 42-5279-002-04 All Lots Persona Constrained TASP (Tibial A/S Prov.) Shim, CD, 14mm; 42-5279-004-00 All Lots Persona Constrained TASP (Tibial A/S Prov.) Shim, EF, 10mm; 42-5279-004-02 All Lots Persona Constrained TASP (Tibial A/S Prov.) Shim, EF, 12mm; 42-5279-004-04 All Lots Persona Constrained TASP (Tibial A/S Prov.) Shim, EF, 14mm; 42-5279-006-00 All Lots Persona Constrained TASP (Tibial A/S Prov.) Shim, GH, 10mm; 42-5279-006-02 All Lots Persona Constrained TASP (Tibial A/S Prov.) Shim, GH, 12mm; 42-5279-006-04 All Lots Persona Constrained TASP (Tibial A/S Prov.) Shim, GH, 14mm; 42-5279-008-00 All Lots Persona Constrained TASP (Tibial A/S Prov.) Shim, J, 10mm; 42-5279-008-02 All Lots Persona Constrained TASP (Tibial A/S Prov.) Shim, J, 12mm; 42-5279-008-04 All Lots Persona Constrained TASP (Tibial A/S Prov.) Shim, J, 14mm; 42-5279-003-00 All Lots Persona TASP (Tibial A/S Provisional) Shim, CD, 10mm; 42-5279-003-01 All Lots Persona TASP (Tibial A/S Provisional) Shim, CD, 11mm; 42-5279-003-02 All Lots Persona TASP (Tibial A/S Provisional) Shim, CD, 12mm; 42-5279-003-03 All Lots Persona TASP (Tibial A/S Provisional) Shim, CD, 13mm; 42-5279-003-04 All Lots Persona TASP (Tibial A/S Provisional) Shim, CD, 14mm; 42-5279-005-00 All Lots Persona TASP (Tibial A/S Provisional) Shim, EF, 10mm; 42-5279-005-01 All Lots Persona TASP (Tibial A/S Provisional) Shim, EF, 11mm; 42-5279-005-02 All Lots Persona TASP (Tibial A/S Provisional) Shim, EF, 12mm; 42-5279-005-03 All Lots Persona TASP (Tibial A/S Provisional) Shim, EF, 13mm; 42-5279-005-04 All Lots Persona TASP (Tibial A/S Provisional) Shim, EF, 14mm; 42-5279-007-00 All Lots Persona TASP (Tibial A/S Provisional) Shim, GH, 10mm; 42-5279-007-01 All Lots Persona TASP (Tibial A/S Provisional) Shim, GH, 11mm; 42-5279-007-02 All Lots Persona TASP (Tibial A/S Provisional) Shim, GH, 12mm; 42-5279-007-03 All Lots Persona TASP (Tibial A/S Provisional) Shim, GH, 13mm; 42-5279-007-04 All Lots Persona TASP (Tibial A/S Provisional) Shim, GH, 14mm.

    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