Reported Feb 13, 2013 · Terminated
Trilogy Acetabular Shell with Cluster Holes. The Trilogy Acetabular System is indicated for either cemented or…
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 with Cluster Holes. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.
- Lot codes and dates
3,260 of 3,260 codes
003697330036962961216911617507736177061061734420618803556194170961687733610762276148931861716316618257846206392361215851612169096126315661483182616558306170919361825783618551886195710461580848619433406206525362076915612158556165582961655831617834696187361661883392618833936196470261978754614390366191139462052806619571026121585061263155613749496151167961536418616654466171631461734423617681996178347061801116618604456186407461864075619163236193831861991357614354956201062361967998
- 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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