6 DEGREE COCR FEM HEAD (various sizes) and 6 DEG UNIPOLAR FEMORAL HE
Medical device recall Z-1033-2014. 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?
6 DEGREE COCR FEM HEAD (various sizes) and 6 DEG UNIPOLAR FEMORAL HE
7,044,680 total, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
60248716 61500239 60124919 60193878 60227863 60305825 60451065 60796836 61144521 60227864 61144525 61887185 62054654 366155 60227791 60300577 60607124 60671459 60774007 60758129 60807553 60973105 60807553R 60227802 60892289 61462907…
Every code shown here, 1,993 characters
60248716 61500239 60124919 60193878 60227863 60305825 60451065 60796836 61144521 60227864 61144525 61887185 62054654 366155 60227791 60300577 60607124 60671459 60774007 60758129 60807553 60973105 60807553R 60227802 60892289 61462907 61586239 60900891 366160 369922 60114470 60153496 60177429 60197992 60227792 60265896 60308809 60382234 60499745 60552245 60737193 60929071 61052827 61203376 61713707 61864130 61866007 60265896R 369929 370590 60107297 60125487 60192043 60266060 60541831 60724231 60743135 61099150 61589279 61666186 61743037 62005415 369930 60114471 60130005 60134697 60134698 60150444 60162851 60173086 60173087 60192044 60197993 60215876 60225025 60246461 60247733 60266062 60294572 60308811 60323678 60362748 60423131 60476815 60535978 60623842 60671476 60728078 60774008 60929072 61002145 61099151 61160409 61203377 61304707 61401714 61587536 61652334 61670828 61732726 61751518 61837152 61911472 62005416 60114471R 369923 60153497 60197994 60308812 60541835 60608604 60747329 60940009 61780614 62005414 60153497R 366158 369931 60107298 60114472 60125488 60147971 60169666 60191454 60222124 60240111 60247734 60282817 60362750 60423132 60499746 60605096 60671478 60732860 60810352 60940010 61052828 61160410 61401715 61645997 61666187 61732727 61751519 61887182 60114473 60128960 60184947 60222125 60265894 60294574 60340822 60403879 60440338 60529671 60566374 60597607 60623844 60699106 60728079 60774009 60800969 60847639 60929073 60929075 61052829 61052830 61099152 61160411 61179796 61224840 61281512 61462909 61530673 61543470 61589278 61603830 61618474 61713704 61732725 61758468 61801238 61808407 61833352 61864131 61866008 61906271 61957512 61977935 62038434 62094968 60099535 60124920 60192050 60233947 60265898 60294573 60323679 60359305 60392803 60440339 60476817 60529670 60541839 60586138 60623849 60699107 60740543 60774010 60806205 60821878 60900890 60929076 60940011 60977427 61002171 61052831 61099153 61099154 61160412 61179797 61224841 61322982 61350125…
FDA’s list runs to 5,872 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 5,872 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.