FDA (Devices) recall action 63531

Zimmer, Inc. recalled 8 products on 2013-02-13

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.

Products: 8
Announced: 2013-02-13
Critical: 0
Units: 2,207,616

Why these products were recalled

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.

1–8 of 8

HighFDA (Devices)··2013-02-13
Zimmer Recalls Trilogy Acetabular Shells for Porosity Defects
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.
Product
Trilogy F/M Acetabular Shell without holes SOLID HA. Several ODs: 38MM, 40MM, 42MM, 44MM, 46MM, 48MM, 50MM, 52MM, 54MM, 56MM, 58MM, 60MM, 62MM, 64MM, 66MM, 68MM, 70MM. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing…
Category
Distribution
0 states
HighFDA (Devices)··2013-02-13
Zimmer Recalls Trilogy Acetabular Shells for Porosity Specification Defects
Zimmer, Inc. is recalling Trilogy Acetabular Shell Spiked units because some may have porosity levels below the required specification.
Product
Trilogy Acetabular Shell Spiked. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.
Category
Distribution
0 states
HighFDA (Devices)··2013-02-13
Zimmer Recalls Trilogy Acetabular Shells Due to Porosity Defect
Zimmer, Inc. is recalling Trilogy Acetabular AB Shells with Holes because some units may have porosity below the specified range.
Product
Trilogy Acetabular AB Shells with Holes. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.
Category
Distribution
0 states
HighFDA (Devices)··2013-02-13
Zimmer Recalls Trilogy Acetabular Shells for Porosity Defect
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.
Product
Trilogy F/M Acetabular Shell without holes. Several ODs: 40MM, 42MM, 44MM, 46MM, 48MM, 50MM, 52MM, 54MM, 56MM, 58MM, 60MM, 62MM, 64MM, 66MM, 68MM, 70MM. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for…
Category
Distribution
0 states
HighFDA (Devices)··2013-02-13
Zimmer Recalls Trilogy Acetabular Shells Due to Porosity Defect
Zimmer, Inc. is recalling Trilogy Acetabular Shells because some units may have porosity below the specified range, potentially affecting the device's performance.
Product
Trilogy Acetabular Shell with Cluster Holes. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.
Category
Distribution
0 states
HighFDA (Devices)··2013-02-13
Zimmer Recalls Trilogy Acetabular Shells with Porosity Defects
Zimmer, Inc. is recalling Trilogy Acetabular Shells with holes because some units have porosity below the specified range, which may affect bone ingrowth.
Product
Trilogy Acetabular Shells with Holes. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.
Category
Distribution
0 states
HighFDA (Devices)··2013-02-13
Zimmer Recalls Trilogy Acetabular Shells Due to Porosity Defects
Zimmer, Inc. is recalling Trilogy Acetabular AB Shells because some units have porosity levels below the required specification.
Product
Trilogy Acetabular AB Shells with Cluster Holes. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.
Category
Distribution
0 states
HighFDA (Devices)··2013-02-13
Zimmer Recalls Trilogy Acetabular Shells Due to Porosity Defects
Zimmer, Inc. is recalling Trilogy F/M Acetabular Shells with Uni-Hole because some units have porosity below the specified range.
Product
Trilogy F/M Acetabular Shell with Uni-Hole. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.
Category
Distribution
0 states