Trident PSL HA Solid Back 50 mm Includes Dome Hole Plug Ref 540-11-50E Intended for cementl...
FDA Recall #Z-1043-2015 — Class II — December 15, 2014
Product Description
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.
Reason for Recall
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.
Recalling Firm
Stryker Howmedica Osteonics Corp. — Mahwah, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
seven units
Distribution
Nationwide Distribution including NY, OH, PA, and TX.
Code Information
510K 983382 Lot code 49073501
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated