Reported Feb 13, 2013 · Terminated
Trilogy Acetabular Shells with Holes. The Trilogy Acetabular System is indicated for either cemented or uncemented use…
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 Shells with 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
1,740 of 1,740 codes
615677306155808161611792615598436156773161611793612158830036972800369696619304016145987061611794615641356120189661292658617834346191519400369729003696806192167561638695619151956190618061808994614257966158082461471012612631446120189700369730003700280037020100370605003704490036962861996704617790266153355861758219614558106145221161911378615968696173441961783435617949286120184561783436620558206158082561825846620226936158082661638696618892556126314661281167613210486132908461471011
- 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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