FDA-Device2015-03-11Class II

LFT v40 Femoral Head; Catalog Number 6260-9-032; V40 CoCr LFit Head 32mm/-4. Designed to be assembled onto a femoral hip stem trunnion during surgery for a total hip arthroplasty.

Stryker Howmedica Osteonics Corp.
Hazard

Three customer complaints were received for the same batch of V40 LFIT Vitallium femoral heads (part number 6260-9-032, lot 48681201) alleging that the femoral head couldn't be assembled with its corresponding V40 stem trunnion.

Sold states
Distributed in the states of GA, MA, NC, NY & PA.
Affected count
9 units
Manufactured in
325 Corporate Dr, N/A, Mahwah, NJ, United States
Products
LFT v40 Femoral Head; Catalog Number 6260-9-032; V40 CoCr LFit Head 32mm/-4. Designed to be assembled onto a femoral hip stem trunnion during surgery for a total hip arthroplasty.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1241-2015

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