Reported Feb 13, 2013 · Terminated
Trilogy Acetabular Shell Spiked. The Trilogy Acetabular System is indicated for either cemented or uncemented use in…
Zimmer, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zimmer, Inc. · 345 E Main St · Warsaw, IN · 46580-2746
Is this the product you have?
- Trilogy Acetabular Shell Spiked. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.
- Lot codes and dates
184 of 184 codes
003696420036964800370032003696566164233400369644618328056181745561269936614126316163056400369407616423376132469461630563612699376182583761548181618464906194102961952408613290956142126361548182616423366098313361237717614212640036966061734272620013106187360661548185612378086154818461642338609193156142126061955590615481866182584161215919613210816184648861421258617620056146914261803767612129226132469561630550612699406126994161431735614691436154819061642339616305676124647561548191
- Amount recalled
- 275,952 units
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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