BEUDAMED
    FDA Enforcement Class II Terminated

    Poly Component Trial, MPCS, packaged in the following sizes and configurations: a) Poly Component Trial - MPCS 3x10L, REF 90-SRK-192310 b) Poly Component Trial - MPCS 3x10R, REF 90-SRK-191310 c) Poly Component Trial - MPCS 3x12L, REF 90-SRK-192312 d) Poly Component Trial - MPCS 3x12R, REF 90-SRK-191312 e) Poly Component Trial - MPCS 3x14L, REF 90-SRK-192314 f) Poly Component Trial - MPCS 3x14R, REF 90-SRK-191314 g) Poly Component Trial - MPCS 4x10L, REF 90-SRK-192410 h) Poly Component Trial - MPCS 4x10R, REF 90-SRK-191410 i) Poly Component Trial - MPCS 4x12L, REF 90-SRK-192412 j) Poly Component Trial - MPCS 4x12R, REF 90-SRK-191412 k) Poly Component Trial - MPCS 4x14L, REF 90-SRK-192414 l) Poly Component Trial - MPCS 4x14R, REF 90-SRK-191414 m) Poly Component Trial - MPCS 5x10L, REF 90-SRK-192510 n) Poly Component Trial - MPCS 5x10R, REF 90-SRK-191510 o) Poly Component Trial - MPCS 5x12L, REF 90-SRK-192512 p) Poly Component Trial - MPCS 5x12R, REF 90-SRK-191512 q) Poly Component Trial - MPCS 5x14L, REF 90-SRK-192514 r) Poly Component Trial - MPCS 5x14R, REF 90-SRK-191514 s) Poly Component Trial - MPCS 6x10L, REF 90-SRK-192610 t) Poly Component Trial - MPCS 6x10R, REF 90-SRK-191610 u) Poly Component Trial - MPCS 6x12L, REF 90-SRK-192612 v) Poly Component Trial - MPCS 6x12R, REF 90-SRK-191612 w) Poly Component Trial - MPCS 6x14L, REF 90-SRK-192614 x) Poly Component Trial - MPCS 6x14R, REF 90-SRK-191614 The Responsive Orthopedics (RO) Total Knee Arthroplasty (TKA) System is intended to restore alignment, stability, range of motion, and alleviate pain by replacing the articulating surfaces of the knee joint.

    Recall: Z-1513-2017 · Reported March 29, 2017

    Enforcement

    Recall Number
    Z-1513-2017
    Event ID
    76694
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Sofamor Danek USA Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 29, 2017
    Initiation Date
    February 20, 2017
    Classification Date
    March 21, 2017
    Termination Date
    October 27, 2017
    Address
    1800 Pyramid Pl, Memphis, TN, 38132-1703, United States

    Description

    Poly Component Trial, MPCS, packaged in the following sizes and configurations: a) Poly Component Trial - MPCS 3x10L, REF 90-SRK-192310 b) Poly Component Trial - MPCS 3x10R, REF 90-SRK-191310 c) Poly Component Trial - MPCS 3x12L, REF 90-SRK-192312 d) Poly Component Trial - MPCS 3x12R, REF 90-SRK-191312 e) Poly Component Trial - MPCS 3x14L, REF 90-SRK-192314 f) Poly Component Trial - MPCS 3x14R, REF 90-SRK-191314 g) Poly Component Trial - MPCS 4x10L, REF 90-SRK-192410 h) Poly Component Trial - MPCS 4x10R, REF 90-SRK-191410 i) Poly Component Trial - MPCS 4x12L, REF 90-SRK-192412 j) Poly Component Trial - MPCS 4x12R, REF 90-SRK-191412 k) Poly Component Trial - MPCS 4x14L, REF 90-SRK-192414 l) Poly Component Trial - MPCS 4x14R, REF 90-SRK-191414 m) Poly Component Trial - MPCS 5x10L, REF 90-SRK-192510 n) Poly Component Trial - MPCS 5x10R, REF 90-SRK-191510 o) Poly Component Trial - MPCS 5x12L, REF 90-SRK-192512 p) Poly Component Trial - MPCS 5x12R, REF 90-SRK-191512 q) Poly Component Trial - MPCS 5x14L, REF 90-SRK-192514 r) Poly Component Trial - MPCS 5x14R, REF 90-SRK-191514 s) Poly Component Trial - MPCS 6x10L, REF 90-SRK-192610 t) Poly Component Trial - MPCS 6x10R, REF 90-SRK-191610 u) Poly Component Trial - MPCS 6x12L, REF 90-SRK-192612 v) Poly Component Trial - MPCS 6x12R, REF 90-SRK-191612 w) Poly Component Trial - MPCS 6x14L, REF 90-SRK-192614 x) Poly Component Trial - MPCS 6x14R, REF 90-SRK-191614 The Responsive Orthopedics (RO) Total Knee Arthroplasty (TKA) System is intended to restore alignment, stability, range of motion, and alleviate pain by replacing the articulating surfaces of the knee joint.

    Reason

    The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken.

    Code Info

    Lot Numbers: a) REF 90-SRK-192310, TU53744-01 b) REF 90-SRK-191310, TU53741-01 c) REF 90-SRK-192312, TU53745-01 d) REF 90-SRK-191312, TU53742-01 e) REF 90-SRK-192314, TU53746-01 f) REF 90-SRK-191314, TU53743-01 g) REF 90-SRK-192410, TU53744-02 h) REF 90-SRK-191410, TU53741-02 i) REF 90-SRK-192412, TU53745-02 j) REF 90-SRK-191412, TU53742-02 k) REF 90-SRK-192414, TU53746-02 l) REF 90-SRK-191414, TU53743-02 m) REF 90-SRK-192510, TU53744-03 n) REF 90-SRK-191510, TU53741-03 o) REF 90-SRK-192512, TU53745-03 p) REF 90-SRK-191512, TU53742-03 q) REF 90-SRK-192514, TU53746-03 r) REF 90-SRK-191514, TU53743-03 s) REF 90-SRK-192610, TU53744-04 t) REF 90-SRK-191610, TU53741-04 u) REF 90-SRK-192612, TU53745-04 v) REF 90-SRK-191612, TU53742-04 w) REF 90-SRK-192614, TU53746-04 x) REF 90-SRK-191614, TU53743-04

    Distribution

    US distribution to AR, MA

    Quantity

    72 units