FDA-Device2016-11-16Class II
LFIT Anatomic V40 Femoral Head, Low Friction Ion Treatment, Sterile, 36 mm, REF 6260-9-236; Modular components designed to be locked onto a femoral hip stem trunnion during surgery for total hip replacement.
Stryker Howmedica Osteonics Corp.
Hazard
Stryker received several complaints describing incidence of harm secondary to taper lock failure for specific lots of numerous catalog numbers of LFIT Anatomic CoCr V40 Femoral Heads.
Sold states
US Nationwide and Internationally
Affected count
42,519 units (total Catalog numbers)
Manufactured in
325 Corporate Dr, Mahwah, NJ, United States
Products
LFIT Anatomic V40 Femoral Head, Low Friction Ion Treatment, Sterile, 36 mm, REF 6260-9-236; Modular components designed to be locked onto a femoral hip stem trunnion during surgery for total hip replacement.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0378-2017Don't want to check this manually?
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