Medical device recalls Moderate risk

Corin USA Limited recalls Trinity Acetabular System Product Usage - Total Hip Replacement.

Recall date
January 29, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1526-2016
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 System Product Usage - Total Hip Replacement.

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