—#133157

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.

FDA product code: JDI — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K010757
Affected lot / code info: Lot Code 48681201

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Stryker Howmedica Osteonics Corp.
Address: 325 Corporate Dr, Mahwah, New Jersey 07430-2002

Distribution

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

Timeline

Recall initiated: 2015-02-03
Posted by FDA: 2015-03-03
Terminated: 2017-04-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #133157. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.