BEUDAMED
    FDA Enforcement Class II Terminated

    Specialist 2 Intramedullary (SP2 IM) Rod 400mm Instrument (PN 96-6120) The SP2 IM Rod 400mm Instrument (PN 96-6120) is used in both primary and revision P.F.C.¿ SIGMA¿ knee procedures to align the femoral locating device and distal femoral cutting block. It is also used with the IM tibial resection. This rod is included with the P.F.C.¿ SIGMA¿ Specialist¿ 2 (SP2 / SPII) Primary Knee Instruments, the P.F.C.¿ SIGMA¿ Specialist ¿ 2 (SP2 / SPII) Revision Knee Instruments, and P.F.C. ¿ SIGMA¿ High Performance (HP) Primary Knee Instruments

    Recall: Z-0111-2016 · Reported October 14, 2015

    Enforcement

    Recall Number
    Z-0111-2016
    Event ID
    72113
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    DePuy Orthopaedics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 14, 2015
    Initiation Date
    September 8, 2015
    Classification Date
    October 7, 2015
    Termination Date
    July 3, 2018
    Address
    700 Orthopaedic Dr, N/A, Warsaw, IN, 46582-3994, United States

    Description

    Specialist 2 Intramedullary (SP2 IM) Rod 400mm Instrument (PN 96-6120) The SP2 IM Rod 400mm Instrument (PN 96-6120) is used in both primary and revision P.F.C.¿ SIGMA¿ knee procedures to align the femoral locating device and distal femoral cutting block. It is also used with the IM tibial resection. This rod is included with the P.F.C.¿ SIGMA¿ Specialist¿ 2 (SP2 / SPII) Primary Knee Instruments, the P.F.C.¿ SIGMA¿ Specialist ¿ 2 (SP2 / SPII) Revision Knee Instruments, and P.F.C. ¿ SIGMA¿ High Performance (HP) Primary Knee Instruments

    Reason

    DePuy Orthopaedics, Inc. is initiating a voluntary recall of select lots of the Specialist 2 Intramedullary Rod 400mm Instrument (PN 96-6120) due to complaints of the rod fracturing and leaving a portion of the rod in patients.

    Code Info

    SP2 IM Rod 400mm Instruments (96-6120) manufactured with 455 stainless steel (SS) or 17-4 SS; CATALOG NO. : 96-6120; GTIN NO.: 10603295246893; Lots: Manufactured with 455 Stainless Steel, Labeled Lot #s-C98CS4; DE5P34; DE5RP4; D95AN4; EB5FV4; FA4G94; DE1FA4; DF4H44; DG9LK4; EB5GH4; EC9JY4; EF4DJ4; FD8MP4; FH8JA4; DG9L64; DJ5E34; DK3E34; EJ7AP4; DK3FE4; EJ7A34; ES2G64; ES2HA4; FH8JX4; ES2HY4; EX5L44; C3JHN4; EX5MS4; C3JHS4; E2SD44; C3JHF4; C4GA54; C4GBT4; C4GCC4; C52F14; C52F74; C52GL4; C52GV4; C67N14; C98BF4; TBACC; TBACZ; FJ4E74; TBCOJ; & Manufactured with 17-4 Stainless Steel- Etched Lot #s- H0797; H0100; H0199; H0200; H0298; H0301; H0396; H0399; H0401; H0495; H0499; H0530; H0596; H0598; H0600; H0601; H0696; H0699; H0796; H0797; H0800; H0899; H0900; H0997; H0998; H1095; H1097; H1195; H1198; H1297; H1298; H1299

    Distribution

    Worldwide Distribution - US including AL; AZ; CA; CO; CT; DC; FL; GA; HI; IA; IL; IN; KY; LA; MA; MD; ME; MI; MN; MO; MS; MT; NC; NE; NH; NJ; NV; NY; OH; OR; PA; RI; SC; TN; TX; UT; VA; VT; WA; WI; and WV and Internationally to ARGENTINA; AUSTRALIA; AUSTRIA; BELGIUM; BRAZIL; CANADA; CHILE; COLOMBIA; CZECH REPUBLIC; EGYPT; FRANCE; GERMANY; GREECE; INDIA; ISRAEL; ITALY; KOREA; Mexico; NEW ZEALAND; NORWAY; P R CHINA; PANAMA; PERU; POLAND; RUSSIA; SINGAPORE; SLOVENIA; SOUTH AFRICA; SWITZERLAND; UAE; UK; URUGUAY; VENEZUELA; and VIETNAM.

    Quantity

    7488