12/14 UNIPOLAR FEMORAL HE VERSYS CEM LD/FX SZ 11X12 VERSYS CEM LD/FX SZ 12X12 VERSYS CEM LD/FX SZ 14X13…
Medical device recall Z-1029-2014. 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 UNIPOLAR FEMORAL HE VERSYS CEM LD/FX SZ 11X12 VERSYS CEM LD/FX SZ 12X12 VERSYS CEM LD/FX SZ 14X13 VERSYS CEM LD/FX SZ 16X14 VERSYS CEM LD/FX ST 18X15 VERSYS PRESS FIT LD/FX ST VERSYS PRESS FIT LD/FX SZ VERSYS ADVOCATE CEMENTED VERSYS ADVOCATE V-LIGN CE VERSYS CEMENTED FEM STEM VERSYS CT FEM STEM 11X120 VERSYS CT FEM STEM 12X125 VERSYS CT FEM STEM 13X130 VERSYS CT FEM STEM 14X135 VERSYS CT FEM STEM 15X140 VERSYS CT FEM STEM 16X145 VERSYS CT FEM STEM 17X150 VERSYS CEM/REV/CALCAR 13X VERSYS CEM/REV/CALCAR 15X VERSYS CEM/REV/CALCAR 17X VERSYS CEM/REV/CALCAR 19X
7,044,680 total, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
365717 366402 367390 368994 369213 369214 369215 369319 370354 370750 371011 60109630 60142945 60235507 60273068 60339025 60448362 60554135 60784634 60800920 60819863 60884374 60902584 60943291 60971162 60988528 61070891 61100359 61100360…
Every code shown here, 1,995 characters
365717 366402 367390 368994 369213 369214 369215 369319 370354 370750 371011 60109630 60142945 60235507 60273068 60339025 60448362 60554135 60784634 60800920 60819863 60884374 60902584 60943291 60971162 60988528 61070891 61100359 61100360 61176577 61176578 61176579 61632276 61765960 61814863 365718 367382 368346 368981 369034 369220 369221 369268 369269 369320 370432 370439 370542 370733 60114244 60206094 60222003 60282832 60334506 60448361 60554138 60651808 60697870 60737518 60784635 60800012 60819864 60819866 60843493 60866926 60884376 60884377 60928161 60943290 60988523 60997305 60997308 61013936 61013938 61171992 61171994 61171995 61176581 61176582 62124063 62256027 365719 367386 368347 369032 369209 369212 369216 369321 369425 369777 369793 370009 370139 370355 370440 370543 370747 371010 60105214 60105215 60118794 60134658 60150050 60191183 60197679 60217131 60222017 60262516 60280674 60322647 60339026 60362643 60407176 60451001 60535945 60559829 60587995 60597421 60691785 60713743 60756664 60784637 60797521 60810339 60838414 60854443 60866927 60902585 60909206 60928153 60943284 60961115 60961116 60997298 60997302 61013941 61070892 61100361 61100362 61176583 61176587 61284588 61330548 61565671 61633857 61748978 61758460 62010702 62079124 62109109 62200261 62251993 62287497 365720 367387 368348 368993 369033 369266 369267 369322 369426 369794 370011 370147 370356 370441 370544 370734 371009 60118795 60134659 60134660 60150052 60176098 60176099 60191978 60197704 60215816 60218181 60224979 60239685 60262517 60265792 60278841 60294265 60322588 60322648 60339027 60356036 60381913 60381933 60407169 60429439 60446325 60476575 60508194 60529659 60535946 60559830 60574968 60597422 60619977 60645475 60651960 60691790 60709222 60727029 60752694 60758477 60785503 60810318 60822017 60822018 60838415 60862041 60866929 60866930 60909208 60943285 60943288 60943289 60988552 60997310 61019080 61022707 61066053 61066055 61100363 61100364 61135473 61176591 61176592 61206721…
FDA’s list runs to 108,287 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 108,287 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.