Trilogy F/M Acetabular Shell with Uni-Hole. The Trilogy recall
Trilogy F/M Acetabular Shell with Uni-Hole. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing…
Why was Trilogy F/M Acetabular Shell with Uni-Hole. The Trilogy 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
61282267 61633887 61260645 61237937 61500763 61397941 61584769 61199849 61429445 61412089 00369745
- Product
- Trilogy F/M Acetabular Shell with Uni-Hole. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing…
- Recalling firm
- Zimmer, Inc.
- Quantity
- 275,952 units
- Distribution
- 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.
- Recall date
- February 13, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)