Reported Feb 13, 2013 · Terminated
Trilogy Acetabular AB Shells 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 AB Shells 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
- Lot
279 of 279 codes
618240066180462561863921619409386177011861770119618472926203628062041700620417016207456261676075616868436187899162086541078914866177122361236214616849406157645661771214615143246204946561398128615430996172098761738788618386696185162761531431615329886155975361610337616333286163953361667050616809586171450761737663617614406176533661765339617712136177121561800650618076846181099261821391618315586184400561946147619800026199276062005870620114256201693762073253620843926167607861962791
- Lot
- 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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