Zimmer, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0771-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: September 14, 2012

Date Posted: February 13, 2013

Recall Number: Z-0771-2013

Event ID: 63531

Reason for Recall:

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.

Status: Terminated

Product Quantity: 275,952 units

Code Information:

61282267 61633887 61260645 61237937 61500763 61397941 61584769 61199849 61429445 61412089 00369745

Distribution Pattern:

Worldwide Distribution-USA (nationwide) and the countries of Denmark, Germany, Greece, Hungary, Ireland, Italy, Netherlands, Spain, Sweden, UK, Poland, France, Australia, Chile, Canada, India, Japan, New Zealand, Peru, South Africa, Colombia, Ukraine, and UAE.

Voluntary or Mandated:

Voluntary: Firm initiated