Howmedica Osteonics Corp. recalls LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-336

Recall date

May 22, 2018

Source

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

Recall number

Z-2298-2018

FDA classification

Class II

Brand / firm

Howmedica Osteonics Corp.

Sold / distributed

Distributed nationwide. Foreign distribution to Australia, Canada, Chile, China, Brazil, France, Germany, India, Italy, Japan, Malaysia, Netherlands, New Zealand, Poland, Portugal, Romania, Singapore, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

Why it was recalled

The recalling firm has received a higher than expected number of complaints documenting femoral head/hip stem disassociation for certain sizes of femoral heads manufactured prior to March 4, 2011.

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

What was recalled

LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-336