Device recall

EVOS 3.5MM LATERAL PROXIMAL TIBIA PLATE 6 HOLE LEFT 91MM REF72463106

FDA recall source

Recall number

Z-0318-2027

Event id

99904

Status

Open, Classified

FDA classification

Class II

Recalling firm

Smith & Nephew, Inc.

Posted

Oct 30, 2026

Initiated

Sep 6, 2026

Product code

HRS

Device type

Plate, Fixation, Bone

Reason

Incorrect labeling; 3.5MM Partial Articular Lateral Proximal Tibia Plate 6 hole Left 91MM implant labeled and lasered etched as as 3.5MM Lateral Proximal Tibia Plate 6 hole left 91mm implant

Root cause

Labeling Change Control

Quantity

7 units

Code info

Lot: 25MM04429/UDI: 00885556640401

Distribution

US Nationwide distribution in the states of AZ, NV, TX, NM, WA, NY.

Related 510(k)s

K170457K210837K213126

Location

Memphis, TN