Medtronic Sofamor Danek USA Inc: Medical Device Recall in 2017 - (Recall #: Z-1516-2017)

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, PS, packaged in the following sizes and configurations: a) Poly Component Trial - PS 3x10, REF 90-SRK-180310 b) Poly Component Trial - PS 3x12, REF 90-SRK-180312 c) Poly Component Trial - PS 3x14, REF 90-SRK-180314 d) Poly Component Trial - PS 4x10, REF 90-SRK-180410 e) Poly Component Trial - PS 4x12, REF 90-SRK-180412 f) Poly Component Trial - PS 4x14, REF 90-SRK-180414 g) Poly Component Trial - PS 5x10, REF 90-SRK-180510 h) Poly Component Trial - PS 5x12, REF 90-SRK-180512 i) Poly Component Trial - PS 5x14, REF 90-SRK-180514 j) Poly Component Trial - PS 6x10, REF 90-SRK-180610 k) Poly Component Trial - PS 6x12, REF 90-SRK-180612 l) Poly Component Trial - PS 6x14, REF 90-SRK-180614 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-1516-2017

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: 111 units

Code Information:

Lot Numbers: a) REF 90-SRK-180310, TU53738-01 b) REF 90-SRK-180312, TU53739-01 c) REF 90-SRK-180314, TU53740-01 d) REF 90-SRK-180410, TU53738-02 e) REF 90-SRK-180412, TU53739-02 f) REF 90-SRK-180414, TU53740-02 g) REF 90-SRK-180510, TU53738-03 h) REF 90-SRK-180512, TU53739-03 i) REF 90-SRK-180514, TU53740-03 j) REF 90-SRK-180610, TU53738-04 k) REF 90-SRK-180612, TU53739-04 l) REF 90-SRK-180614, TU53740-04

Distribution Pattern:

US distribution to AR, MA

Voluntary or Mandated:

Voluntary: Firm initiated