Device 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.
Z-0771-2013
Product summary
- Firm
- Zimmer, Inc.
- Event
- Event 63531
- Status
- Terminated
- Classification
- Class II
- Quantity
- 275,952 units
- Official record key
device-enforcement:Z-0771-2013
Official wording
Reason: 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.
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.
Derived failure modes
-
Unknown
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.