Corin USA Limited recalls Trinity Acetabular Shell Product Usage: Total Hip Replacement.

Recall date

January 29, 2016

Source

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

Recall number

Z-1527-2016

FDA classification

Class II

Brand / firm

Corin USA Limited

Sold / distributed

Worldwide Distribution - US Nationwide in the states of CA, FL, ID, TX, OK, OH, MA, and NC and the countries of Australia Belgium, Egypt, Germany, Ghana, Italy, Japan, Poland, South Africa and UK.

Why it was recalled

Potential for abrasion of the sterile barrier pouches of the new packaging system.

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

What was recalled

Trinity Acetabular Shell Product Usage: Total Hip Replacement.