12/14 COCR FEMORAL HEAD
Medical device recall Z-1031-2014. 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?
12/14 COCR FEMORAL HEAD (2, 3 and 4); 12/14 FEMORAL HEAD (+7X28M and 7X32M)
7,044,680 total, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
365365 365664 60095144 60106294 60106295 60106296 60109696 60109697 60124944 60124945 60134520 60134521 60138381 60138382 60157045 60157046 60157047 60173107 60173557 60178493 60189233 60190544 60196799 60205060 60205062 60215717 60232508…
Every code shown here, 1,994 characters
365365 365664 60095144 60106294 60106295 60106296 60109696 60109697 60124944 60124945 60134520 60134521 60138381 60138382 60157045 60157046 60157047 60173107 60173557 60178493 60189233 60190544 60196799 60205060 60205062 60215717 60232508 60232571 60236680 60238555 60239170 60239172 60239173 60249946 60250022 60250024 60262696 60262703 60274914 60274915 60274916 60275490 60275491 60275492 60346324 60346325 60349076 60349077 60349078 60349079 60349080 60389118 60392706 60425077 60431157 60431160 60431161 60458471 60466704 60475849 60484210 60499766 60508292 60517078 60524278 60535550 60535551 60541380 60541381 60568674 60579071 60587849 60597445 60597446 60610372 60610373 60623786 60627203 60656086 60664595 60670142 60677138 60687291 60687418 60687419 60718653 60722394 60732757 60746715 60758427 60758430 60769368 60780501 60796169 60806142 60816001 60821870 60823970 60838548 60847561 60857285 60902859 60926643 60932110 60946189 60960585 60985058 60985059 60985060 60991401 61005341 61022599 61035615 61035616 61052152 61070012 61070013 61070014 61089088 61089090 61092840 61092841 61111756 61135439 61135440 61138014 61138016 61167124 61178515 61178688 61184545 61203739 61203740 61223370 61223371 61245055 61245056 61256831 61261936 61261937 61261938 61269109 61288320 61304610 61304612 61338105 61338107 61338108 61343023 61350054 61368478 61371507 61373326 61383291 61383292 61401624 61401626 61450665 61450666 61450667 61469240 61469241 61469242 61488251 61488252 61488253 61502828 61502829 61502830 61548470 61548474 61548476 61548479 61548480 61548481 61600727 61600731 61600733 61600736 61600738 61634945 61659973 61659975 61674846 61686460 61686461 61686462 61720170 61727773 61736757 61743025 61743026 61744785 61760260 61769457 61769458 61769459 61777541 61780566 61780567 61803288 61803289 61803290 61826627 61826628 61826629 61826630 61826631 61829226 61847059 61847060 61855260 61870131 61870132 61870133 61870134 61887176 61904394 61904395 61938358 61938359 61938360…
FDA’s list runs to 98,825 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 98,825 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.