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Recall Observatory FDA recall evidence

Device product

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.

Z-1241-2015

February 03, 2015

Class II

Product summary

Firm
Stryker Howmedica Osteonics Corp.
Event
Event 70338
Status
Terminated
Classification
Class II
Quantity
9 units
Official record key
device-enforcement:Z-1241-2015

Official wording

Reason: 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.

Code information: Lot Code 48681201

Distribution pattern: Distributed in the states of GA, MA, NC, NY & PA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.