FDA (Devices) recall action 63531
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.
Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012, the firm expanded the recall action to include lots of Uni-Hole Trilogy Acetabular System shells.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Zimmer, Inc. is recalling Trilogy Acetabular Shells with holes because some units have porosity below the specified range, which may affect bone ingrowth.
Zimmer, Inc. is recalling Trilogy F/M Acetabular Shells because some units have porosity below the specified range. The recall includes 275,952 units distributed worldwide.
Zimmer, Inc. is recalling Trilogy Acetabular Shell Spiked units because some may have porosity levels below the required specification.
Zimmer, Inc. is recalling Trilogy Acetabular AB Shells with Holes because some units may have porosity below the specified range.
Zimmer, Inc. is recalling Trilogy F/M Acetabular Shells because some units have porosity levels below the specified range. The recall includes units manufactured since March 2009 and was expanded in October 2012.
Zimmer, Inc. is recalling Trilogy F/M Acetabular Shells with Uni-Hole because some units have porosity below the specified range.
Zimmer, Inc. is recalling Trilogy Acetabular AB Shells because some units have porosity levels below the required specification.
Zimmer, Inc. is recalling Trilogy Acetabular Shells because some units may have porosity below the specified range, potentially affecting the device's performance.