Synthes (USA) Products LLC recalls Synthes Periarticular Insertion Handle for 4.5mm LCP Proximal Tibia Plates and Periarticular Aiming Arm for 4.5mm LCP P…

Recall date

September 14, 2015

Source

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

Recall number

Z-0024-2016

FDA classification

Class II

Brand / firm

Synthes (USA) Products LLC

Sold / distributed

Nationally

Why it was recalled

Affected lots of Periarticular Aiming Arms and Insertion Handles (Part Numbers 03.120.001, 03.120.002, 03.120.004 and 03.120.005) for the 4.5 mm LCP Proximal Tibia Plates are not able to be secured to the subsequent versions of these devices as intended.

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

What was recalled

Synthes Periarticular Insertion Handle for 4.5mm LCP Proximal Tibia Plates and Periarticular Aiming Arm for 4.5mm LCP Proximal Tibia Plates