FDA (Devices) recall action 80059
The FDA (Devices) publishes a recall like this one as 8 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 8 pages.
The recalling firm has received a higher than expected number of complaints documenting femoral head/hip stem disassociation for certain sizes of femoral heads manufactured prior to March 4, 2011.
The agency’s own wording, quoted from the enforcement report.
Howmedica Osteonics Corp. is recalling specific LFIT Anatomic CoCr Femoral Heads because of a higher than expected number of complaints regarding disassociation from the hip stem.
Howmedica Osteonics Corp. is recalling LFIT Anatomic CoCr Femoral Heads because of a higher than expected number of complaints regarding disassociation from the hip stem.
Howmedica Osteonics Corp. is recalling specific lots of LFIT Anatomic CoCr Femoral Heads due to a higher than expected number of complaints about femoral head and hip stem disassociation.
Howmedica Osteonics Corp. is recalling specific lots of LFIT Anatomic CoCr Femoral Heads due to a higher than expected number of complaints about femoral head and hip stem disassociation.
Howmedica Osteonics Corp. is recalling specific LFIT Anatomic CoCr Femoral Heads because of a higher than expected number of complaints regarding disassociation from the hip stem.
Howmedica Osteonics Corp. is recalling specific lots of LFIT Anatomic CoCr Femoral Heads due to a higher than expected number of complaints about femoral head and hip stem disassociation.
Howmedica Osteonics Corp. is recalling LFIT Anatomic CoCr Femoral Heads due to a higher than expected number of complaints about disassociation from the hip stem.
Howmedica Osteonics Corp. is recalling specific lots of LFIT Anatomic CoCr Femoral Heads due to higher-than-expected complaints of femoral head/hip stem disassociation.