Synthes (USA) Products LLC recalls LCP Dia-Meta Volar Distal Radius Plate 15 H Shaft/LT-Sterile; Indicated for fractures, osteotomies, and non-unions of t…

Recall date

May 2, 2016

Source

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

Recall number

Z-1949-2016

FDA classification

Class II

Brand / firm

Synthes (USA) Products LLC

Sold / distributed

Distributed to one customer: Colorado

Why it was recalled

Product incorrectly packaged. The labels on the outside of the box and on the LCP Dia-Meta Volar Distal Radius Plate inside the box are correct; however, the preprinted box which contains the LCP-Dia-Meta Volar Distal Radius Plate is incorrect. The box is preprinted for a 4.5 mm LCP Condylar Plate - Distal Femur.

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

What was recalled

LCP Dia-Meta Volar Distal Radius Plate 15 H Shaft/LT-Sterile; Indicated for fractures, osteotomies, and non-unions of the radius and other small bones.