Smith & Nephew, Inc. recalls JOURNEY II UNI RESECTION PREP TRIAL, LEFT MEDIAL/ RIGHT LATERAL - Product Usage: The JOURNEY II Uni Resection Prep Tria…

Recall date

January 28, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2132-2020

FDA classification

Class II

Brand / firm

Smith & Nephew, Inc.

Sold / distributed

US Nationwide distribution.

Why it was recalled

The spike rail was manufactured with an oversized thru-hole which could potentially cause the dowel pin to fall out and the device to disassemble.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

JOURNEY II UNI RESECTION PREP TRIAL, LEFT MEDIAL/ RIGHT LATERAL - Product Usage: The JOURNEY II Uni Resection Prep Trial is a reusable surgical instrument used during range of motion trialing to assess joint tension and component alignment during surgery. The provisional moveable spikes (spike rail) aids in provisional fixation of the trial. SIZE 1, CATALOG NUMBER: REF 74035821 SIZE 2, CATALOG NUMBER: REF 74035822 SIZE 3, CATALOG NUMBER: REF 74035823 SIZE 4, CATALOG NUMBER: REF 74035824 SIZE 5, CATALOG NUMBER: REF 74035825 SIZE 6, CATALOG NUMBER: REF 74035826 SIZE 7, CATALOG NUMBER: REF 74035827 SIZE 8, CATALOG NUMBER: REF 74035828 SIZE 9, CATALOG NUMBER: REF 74035829 SIZE 10, CATALOG NUMBER: REF 74035830