Medtronic Sofamor Danek USA Inc: Medical Device Recall in 2017 - (Recall #: Z-1513-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product 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.

Product Classification:

Class II

Date Initiated: February 20, 2017

Date Posted: March 29, 2017

Recall Number: Z-1513-2017

Event ID: 76694

Reason for Recall:

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

Status: Terminated

Product Quantity: 72 units

Code Information:

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 Pattern:

US distribution to AR, MA

Voluntary or Mandated:

Voluntary: Firm initiated