FDA-Device2018-07-11Class II
LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-136
Howmedica Osteonics Corp.
Hazard
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.
Sold states
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.
Manufactured in
325 Corporate Dr, Mahwah, NJ, United States
Products
LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-136
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2295-2018Don't want to check this manually?
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