Trilogy Acetabular AB Shells with Cluster Holes
Medical device recall Z-0774-2013. 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 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.
275,952 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Lot 61824006 61804625 61863921 61940938 61770118 61770119 61847292 62036280 62041700 62041701 62074562 61676075 61686843 61878991 62086541 07891486 61771223 61236214 61684940 61576456 61771214 61514324 62049465 61398128 61543099 61720987…
Every code shown here, 1,993 characters
Lot 61824006 61804625 61863921 61940938 61770118 61770119 61847292 62036280 62041700 62041701 62074562 61676075 61686843 61878991 62086541 07891486 61771223 61236214 61684940 61576456 61771214 61514324 62049465 61398128 61543099 61720987 61738788 61838669 61851627 61531431 61532988 61559753 61610337 61633328 61639533 61667050 61680958 61714507 61737663 61761440 61765336 61765339 61771213 61771215 61800650 61807684 61810992 61821391 61831558 61844005 61946147 61980002 61992760 62005870 62011425 62016937 62073253 62084392 61676078 61962791 62036281 61338624 61581713 61817237 61581712 61581714 61656292 61757712 61765340 61821393 61236215 61236216 61338666 61398129 61514325 61514326 61532990 61581711 61727955 61738789 61771216 61771221 61784813 61796131 61831565 61838671 61844006 61851628 61946319 61992761 61810993 61930116 62036282 61610338 61639534 61962792 61998856 62011426 61684942 61667051 62078581 61676591 61476225 61639535 62049467 61543101 61771224 61553782 61734089 62052856 61980006 61236218 61236219 61765337 61831549 62078789 61236217 61531433 61581715 61629973 61656293 61727956 61752676 61771217 61771218 61780740 61791906 61807685 61817238 61831566 61838672 61844007 61860174 62011427 62023771 62073255 61998857 61667052 61676081 61962793 61676592 61338667 61476226 61236220 61236223 61757711 61791907 61709237 61771219 61236224 61236222 61236225 61499616 61532989 61566825 61576457 61639536 61670754 61720991 61742089 61765341 61796132 61801296 61851630 61980010 61236221 61375787 61531434 61531435 61549723 61553783 61629974 61633329 61656294 61714520 61761441 61771220 61771225 61817239 61821392 61831602 61844008 61860172 62023772 61734088 61381468 61771222 61807695 62078790 61271672 61962794 61450095 61935498 62011428 61648309 61831560 61992762 61676593 61684943 61589940 61398130 62073158 62049468 62078791 61236226 61566826 61676594 62052858 61796133 61816923 61926630 61585972 61639537 61761437 61780739 61946148 61227823 61236227 61236228 61658812 61684944…
FDA’s list runs to 2,514 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 2,514 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.