Trilogy F/M Acetabular Shell without holes
Medical device recall Z-0769-2013. 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 F/M Acetabular Shell without holes. Several ODs: 40MM, 42MM, 44MM, 46MM, 48MM, 50MM, 52MM, 54MM, 56MM, 58MM, 60MM, 62MM, 64MM, 66MM, 68MM, 70MM. 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
61216907 61157229 00369603 61452214 00370029 00369698 61176450 00369643 00370031 61454835 00369732 00369699 61216908 61673516 61642322 62065259 61906448 61263152 61454836 61476896 00369630 61775736 61943339 61403525 61642325 61732773…
Every code shown here, 1,952 characters
61216907 61157229 00369603 61452214 00370029 00369698 61176450 00369643 00370031 61454835 00369732 00369699 61216908 61673516 61642322 62065259 61906448 61263152 61454836 61476896 00369630 61775736 61943339 61403525 61642325 61732773 61263539 61642324 61906449 62022702 62076908 61885843 61309789 61928501 61237709 61292681 61407876 61825843 61452216 61817457 61237707 61237708 61271325 61327754 61452215 61452217 61489313 61519975 61536413 61564182 61598285 61642323 00370315 00369632 61744558 61885845 62079957 61732772 61928502 61783457 61825844 61869694 61906453 62010604 61846487 61993146 61642326 61779030 61783460 61906450 62052790 61536692 61487482 61487481 61598295 61632192 61309790 61511677 61455839 61263540 61367254 61321073 61237710 61281183 61455840 00369649 61976102 61788120 61885847 61928503 61801103 61840614 61947562 61996712 61813950 61899040 61911390 62001304 61864069 61536693 61473713 61417315 62076907 61487483 61489314 61281184 61237711 61237712 61642328 61260584 61306613 61329094 61403527 61455843 61598296 61642327 00369605 61642329 61813945 61980779 61947563 62076909 61928504 61955589 61292682 62006523 61801104 61813948 61864070 61885848 61906451 61476897 61612715 61642330 61470887 61417316 61473724 61567576 61256570 61455841 61215903 61237713 61281185 61309791 61397913 61536694 00369645 61728663 61775735 61801102 61864071 61996713 61292684 61642332 61891249 61526509 61611815 61976103 61760310 61768196 61951207 62043439 61235829 61237714 61271326 61429593 61500680 61526508 61611819 61817458 62079956 61260587 61452212 61321074 61403528 61417317 61469130 61500681 61801101 61825845 61911391 62065258 61350519 00369738 00369635 61548179 61928505 61532294 61548180 61642333 61803766 61983681 62036846 61237716 61309792 61403529 61412049 61889258 61256571 61424318 61455846 61476898 62006522 00369803 61921682 61873604 61500682 61318326 61987182 61350520 00369741 00369702 00369639 61452213 00369640 61724206 00369705
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.”
- 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.