Device 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.
Z-0776-2013
Product summary
- Firm
- Zimmer, Inc.
- Event
- Event 63531
- Status
- Terminated
- Classification
- Class II
- Quantity
- 275,952 units
- Official record key
device-enforcement:Z-0776-2013
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: 62054788 61901417 61984072 61901423 61901426 61901427 61901428 61901435 61901437 61278096
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.