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.
FDA Recall Z-1241-2015 · Posted 2015-03-03
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Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeJDI
Date Initiated2015-02-03
Date Terminated2017-04-07
Product Quantity9 units
Reason for Recall
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.
Firm Action
Branches/Agencies were notified of this action by e-mail on December 19, 2014 and were asked to quarantine affected devices. Notification Letters and Product Accountability Forms were sent to Hospital Risk Management and Chief of Orthopaedics via FedEx (with return receipt) by 2/3/2015.
Root Cause
Under Investigation by firm
Distribution Pattern
Distributed in the states of GA, MA, NC, NY & PA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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