Trilogy Acetabular Shell with Cluster Holes
Medical device recall Z-0773-2013. Published in FDA’s Enforcement Report on Feb 13, 2013.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Feb 13, 2013. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 275,952 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
275,952 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
00369733 00369629 61216911 61750773 61770610 61734420 61880355 61941709 61687733 61076227 61489318 61716316 61825784 62063923 61215851 61216909 61263156 61483182 61655830 61709193 61825783 61855188 61957104 61580848 61943340 62065253…
Every code shown here, 1,998 characters
00369733 00369629 61216911 61750773 61770610 61734420 61880355 61941709 61687733 61076227 61489318 61716316 61825784 62063923 61215851 61216909 61263156 61483182 61655830 61709193 61825783 61855188 61957104 61580848 61943340 62065253 62076915 61215855 61655829 61655831 61783469 61873616 61883392 61883393 61964702 61978754 61439036 61911394 62052806 61957102 61215850 61263155 61374949 61511679 61536418 61665446 61716314 61734423 61768199 61783470 61801116 61860445 61864074 61864075 61916323 61938318 61991357 61435495 62010623 61967998 62063924 61216912 61256547 61310909 61483181 61528587 61580847 61580856 61655832 61665445 61673515 61687736 61687737 61687738 61709191 61709195 61744559 61750775 61783468 61794947 61817467 61825786 61846496 61936095 61941382 61999744 61999746 62065252 61237816 61846498 61911393 62052805 61066740 61237813 61237818 61237819 61246512 61246513 61281211 61292688 61350523 61360120 61407892 61417319 61417320 61439040 61487484 61489317 61497389 61511678 61511682 61528591 61542704 61542705 61542706 61665437 61675891 61687735 61709194 61716311 61716312 61734422 61779045 61801115 61817466 61825785 61846495 61846497 61867244 61867245 61881178 61884422 61926356 61934256 61949820 61953119 61999743 61999745 61360117 61439035 61873615 61941383 61978755 62010624 61880358 61263157 61263159 61281209 61283578 61283579 61360119 61360121 61397916 61397917 61407891 61417318 61429477 61439033 61454837 61454838 61454839 61483184 61487486 61489321 61511681 61521915 61528589 61528593 61536415 61536416 61564183 61564184 61580857 61655827 61665436 61665438 61687739 61709190 61716310 61716313 61750774 61809034 61880356 61880357 61934260 61952442 61957101 62036848 62036849 62076914 61292412 61397920 61412058 61528590 61817468 61916324 61939317 61271328 61489316 61884423 61201906 61215853 61216910 61237814 61237815 61237817 61246484 61256546 61260613 61260614 61263154 61263158 61271327 61271329 61281213 61283580 61292686 61292687 61292689 61310908 61324697 61324698…
FDA’s list runs to 37,313 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Sep 14, 2012.
- FDA classified it on Feb 4, 2013.
- FDA’s Enforcement Report published it on Feb 13, 2013.
- FDA terminated it on Jun 20, 2014.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Zimmer, Inc., of Warsaw, IN.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 37,313 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.