Smith & Nephew, Inc. recalls Birmingham Hip Resurfacing Femoral Head: (a) Size 58 mm, REF 74121158 (b) Size 56 mm, REF 74123156

Recall date

May 11, 2018

Source

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

Recall number

Z-2267-2018

FDA classification

Class II

Brand / firm

Smith & Nephew, Inc.

Sold / distributed

OH, TX, CO, TN, MI, PA, NJ

Why it was recalled

The affected devices are manufactured to the same design specification as products intended for sale and use in the US but do not contain the FDA approved labeling (i.e., IFU and Patient Information Brochure). The affected devices were distributed in the US with the IFU intended for use outside of the US

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

What was recalled

Birmingham Hip Resurfacing Femoral Head: (a) Size 58 mm, REF 74121158 (b) Size 56 mm, REF 74123156