HGP II ACETABULAR CUP BON
Medical device recall Z-1025-2014. Published in FDA’s Enforcement Report on Feb 26, 2014.
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 26, 2014. 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
- 7,044,680 total 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?
Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
HGP II ACETABULAR CUP BON
7,044,680 total, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
60623443 61033908 60735135 60134455 61110848 60752636 60843726 61056222 60507678 60849459 60507690 60746629 60373606 60621446 60696755 60796167 60884344 60980958 61056223 61138012 61202414 61336976 61445414 61479406 61614837 61770499…
Every code shown here, 1,998 characters
60623443 61033908 60735135 60134455 61110848 60752636 60843726 61056222 60507678 60849459 60507690 60746629 60373606 60621446 60696755 60796167 60884344 60980958 61056223 61138012 61202414 61336976 61445414 61479406 61614837 61770499 61830570 62081013 62130755 62204493 60358198 60456662 60676065 60740508 60793418 60847420 60906711 60970346 61018601 61089082 61114463 61197927 61265392 61336977 61405285 61445415 61504347 61560488 61612779 61717244 61770502 61830571 61953544 62017892 62081014 62126660 62161132 62194338 62286121 60096604 60191638 60231058 60310154 60403566 60541147 60614769 60652079 60713588 60771842 60809040 60906712 60965173 61013603 61077260 61120020 61191847 61197928 61288037 61336979 61405286 61445416 61504866 61548952 61612780 61649225 61738511 61770503 61830572 61902195 61902196 62017893 62048834 62090584 62204494 62286108 60134456 60196503 60254570 60310198 60400186 60604759 60642280 60687794 60749489 60793419 60838387 60914317 60965174 61018602 61070794 61114467 61180328 61191849 61226932 61296291 61362816 61378482 61405287 61458844 61504348 61548956 61612781 61649239 61687332 61738512 61770504 61801685 61830573 61902198 61902199 62061747 62104331 62130756 62194340 62211466 62315402 60307754 60358199 60537583 60745919 60817921 60884347 60932061 61013580 61077263 61135531 61197929 61283948 61354050 61445417 61458847 61573708 61612782 61649249 61738514 61770505 61830569 61906698 61948762 62104332 62130758 62227608 62308540 60391769 60537584 60614771 60732352 60780619 60838388 60906713 60965175 61013604 61056224 61120060 61180329 61226933 61283949 61336980 61405288 61445418 61479405 61504351 61573709 61623853 61674477 61717245 61760696 61770506 61830575 61902204 62017896 62074012 62104333 62143479 62227609 62308549 60354639 60400189 60503574 60535463 60604758 60616222 60642282 60687795 60756662 60796168 60821835 60875850 60909007 60970354 61035977 61089087 61120021 61180330 61202417 61255507 61296294 61378483 61445419 61458849 61504867 61573710…
FDA’s list runs to 2,285 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 Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.
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 Oct 11, 2013.
- FDA classified it on Feb 20, 2014.
- FDA’s Enforcement Report published it on Feb 26, 2014.
- FDA terminated it on Apr 14, 2017.
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 2,285 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.