Trilogy Acetabular Shell Spiked
Medical device recall Z-0772-2013. 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 Spiked. 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
00369642 00369648 00370032 00369656 61642334 00369644 61832805 61817455 61269936 61412631 61630564 00369407 61642337 61324694 61630563 61269937 61825837 61548181 61846490 61941029 61952408 61329095 61421263 61548182 61642336 60983133…
Every code shown here, 1,655 characters
00369642 00369648 00370032 00369656 61642334 00369644 61832805 61817455 61269936 61412631 61630564 00369407 61642337 61324694 61630563 61269937 61825837 61548181 61846490 61941029 61952408 61329095 61421263 61548182 61642336 60983133 61237717 61421264 00369660 61734272 62001310 61873606 61548185 61237808 61548184 61642338 60919315 61421260 61955590 61548186 61825841 61215919 61321081 61846488 61421258 61762005 61469142 61803767 61212922 61324695 61630550 61269940 61269941 61431735 61469143 61548190 61642339 61630567 61246475 61548191 61630565 61269943 61734270 60983134 61803771 61235835 61324696 61235836 61955591 61321084 61517446 61842609 61869695 00369695 61469149 61215920 61642341 61630551 61548201 61809017 61421267 61548199 61251222 61421266 61783461 61803769 61947736 61952415 61199836 61199839 61283453 61283454 61921683 00369661 61469151 61548205 61952422 61630552 61809012 61642342 61548206 61237809 61923871 61925091 61783462 61403530 61283455 61191067 00370048 00369663 61469152 61215929 61548212 61630569 61923872 61630553 00369638 61469154 00369651 00370752 61975586 00369664 11001720 61490760 62023765 61742082 61222252 61271664 61511137 61629985 61667049 61769838 61844002 61955479 61979981 61227814 61676615 61236278 61549718 61721127 61550409 62159365 61714399 11002260 62052850 07892033 61843998 61384952 61442061 61499614 61532992 61629982 61667062 61754419 61980115 61549720 61461917 61784734 62054500 61511139 61676596 61742071 61857680 61962840 62136223 61203311 62126090 61384953 61979983 07892046 61416489 61737672 61354833 61330560 61456504 62023767 61442060 61354834 07892052 61375761 61450049 62030472 61531423 61581705
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.