Medical device recalls Moderate risk

Stryker Howmedica Osteonics Corp. recalls LFT v40 Femoral Head; Catalog Number 6260-9-032; V40 CoCr LFit Head 32mm/-4. Designed to be assembled onto a femoral hi…

Recall date
February 3, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1241-2015
FDA classification
Class II
Brand / firm
Stryker Howmedica Osteonics Corp.
Sold / distributed
Distributed in the states of GA, MA, NC, NY & PA.

Why it was recalled

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.

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

What was recalled

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.

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