Medical device recalls Moderate risk

Biomet, Inc. recalls BIOMET Custom StageOne Hip Femoral Reinforcement, 9 X 125 MM, Stainless Steel, PMI Instrument, Sterile, Item CP161972.

Recall date
February 26, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1670-2020
FDA classification
Class II
Brand / firm
Biomet, Inc.
Sold / distributed
Worldwide distribution. US distribution to the following states: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mis…

Why it was recalled

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

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

What was recalled

BIOMET Custom StageOne Hip Femoral Reinforcement, 9 X 125 MM, Stainless Steel, PMI Instrument, Sterile, Item CP161972.

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