FDA Device recall Z-1516-2017

Poly Component Trial, PS, packaged in the following sizes and configurations: a) Poly Component Trial - PS 3x10, REF 90-SRK-180310 b) Poly…

FDA Device
Class II
terminated
Published 2017-03-29

On 2017-03-29 the FDA classified a Class II recall of Poly Component Trial, PS, packaged in the following sizes and configurations: a) Poly Component Trial - PS 3x10, REF 90-SRK-180310 b) Poly… by Medtronic Sofamor Danek Usa, citing the dovetails of poly trials, Beta 2.0, were observed as either cracked or broken.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1516-2017
Classification	Class II
Status	terminated
Initiated	2017-02-20
Published	2017-03-29
Last updated	2026-09-13 11:54 UTC
Company	Medtronic Sofamor Danek Usa
Distribution	AR, MA

Product

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

Reason

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

Identifiers

code_info	Lot Numbers: a) REF 90-SRK-180310, TU53738-01 b) REF 90-SRK-180312, TU53739-01 c) REF 90-SRK-180314, TU53740-01 d)… 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

code_info

Lot Numbers: a) REF 90-SRK-180310, TU53738-01 b) REF 90-SRK-180312, TU53739-01 c) REF 90-SRK-180314, TU53740-01 d)…

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1516-2017%22

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