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Stryker Howmedica Osteonics Corp. recalls Trident PSL HA Solid Back 50 mm Includes Dome Hole Plug Ref 540-11-50E Intended for cementless application in a to
Recalled February 11, 2015 · FDA recall Z-1043-2015 · Stryker Howmedica Osteonics
Hazard
Five customer complaints were received for the same batch of Trident PSL Shells (part number 540-11-50E lot 49073501) alleging that when the packages were opened there were no dome holes plugs present. · FDA Class II
Units
seven units
Sold at
Nationwide Distribution including NY, OH, PA, and TX.
Description
Five customer complaints were received for the same batch of Trident PSL Shells (part number 540-11-50E lot 49073501) alleging that when the packages were opened there were no dome holes plugs present.
Product
Trident PSL HA Solid Back 50 mm Includes Dome Hole Plug Ref 540-11-50E Intended for cementless application in a total hip arthroplasty procedure. This system is a two piece ( a shell and a liner) design that is assembled during surgery. The shell is press-fit into the patients prepared acetabulum and a linger (polyethylene or alumina ceramic) is then locked into the shell. The femoral head component of the total hip system articulates with the acetabular liner.
Manufacturer(s)
Stryker Howmedica Osteonics Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →