Z-0776-2013 Class II Terminated
FDA device recall Z-0776-2013 was initiated by Zimmer, Inc. on Sep 14, 2012 and is designated Class II. 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 status is terminated (terminated Jun 20, 2014). Affected quantity: 275,952 units.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 13, 2013
- Initiation Date
- Sep 14, 2012
- Termination Date
- Jun 20, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 275,952 units
Product Description
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.
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.
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.
Code Information
62054788 61901417 61984072 61901423 61901426 61901427 61901428 61901435 61901437 61278096
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0776-2013
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026