Product 66 consists of all product under
Medical device recall Z-1164-2016. Published in FDA’s Enforcement Report on Mar 23, 2016.
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 Mar 23, 2016. 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
- 4353 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?
As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. The affected products are sterile.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Product 66 consists of all product under product code: JDI and same usage: Item no: 785001100 VERSYS ADVOCATE CEMENTED 785001200 VERSYS ADVOCATE CEMENTED 785001220 VERSYS ADVOCATE CEMENTED 785001300 VERSYS ADVOCATE CEMENTED 785001320 VERSYS ADVOCATE CEMENTED 785001400 VERSYS ADVOCATE CEMENTED 785001420 VERSYS ADVOCATE CEMENTED 785001500 VERSYS ADVOCATE CEMENTED 785001520 VERSYS ADVOCATE CEMENTED 785001600 VERSYS ADVOCATE CEMENTED 785001620 VERSYS ADVOCATE CEMENTED 785001700 VERSYS ADVOCATE CEMENTED 785001305 VERSYS ADVOCATE V-LIGN CE 785001325 VERSYS ADVOCATE V-LIGN CE 785001405 VERSYS ADVOCATE V-LIGN CE 785001505 VERSYS ADVOCATE V-LIGN CE 785001525 VERSYS ADVOCATE V-LIGN CE For use in total or hemi hip arthroplasty
4353, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
lot no.: 61983708 62030926 62033221 62036882 62036883 62038355 62075338 62075339 62075340 62097036 62097037 62122103 62122104 62154556 62166260 62171392 62171393 62177323 62178289 62181449 62183156 62183157 62188303 62189403 62192487…
Every code shown here, 1,998 characters
lot no.: 61983708 62030926 62033221 62036882 62036883 62038355 62075338 62075339 62075340 62097036 62097037 62122103 62122104 62154556 62166260 62171392 62171393 62177323 62178289 62181449 62183156 62183157 62188303 62189403 62192487 62193425 62195517 62204536 62206537 62210448 62216685 62222761 62240269 62240270 62240788 62240789 62240790 62240791 62279094 62280474 62284491 62299105 62312497 62312498 62314646 62315889 62317930 62318766 62320172 62324102 62326110 62346579 62354651 61809115 61820812 61911428 62018462 62027424 62028727 62028729 62042580 62042581 62050972 62050973 62050974 62166258 62166259 62167379 62167380 62174631 62174632 62178288 62181453 62186369 62186370 62186371 62194586 62199409 62204537 62210449 62222760 62234477 62234482 62240279 62240792 62240793 62251959 62252977 62252978 62255125 62280475 62284492 62284493 62306522 62306523 62317924 62317925 62317926 62320174 62326111 62332042 62332043 62340067 62340069 62352843 62043467 62075347 62079948 62106810 62128843 62166265 62167376 62188299 62194587 62218121 62240805 62263240 62263242 62301430 62325577 62340074 62344687 61864106 61871776 61891283 61983710 62019782 62036879 62036881 62038359 62043464 62043471 62043472 62046504 62075341 62097039 62097040 62125319 62125321 62166262 62171394 62171395 62171398 62174635 62177326 62181450 62186372 62188304 62189404 62193423 62193424 62199407 62199408 62210451 62215708 62216684 62222759 62240272 62240273 62240281 62240794 62240795 62240796 62263233 62263235 62266495 62278254 62278256 62280476 62284494 62299103 62299104 62311636 62311638 62316417 62316419 62317917 62317927 62320173 62330773 62330774 62332039 62340071 62354649 62362850 61846958 61955607 62038363 62075348 62097043 62106811 62156147 62188301 62194585 62199411 62240806 62282925 62291136 62301431 62325578 61817995 61839052 61839054 61878457 61883398 61883399 61883401 61922364 61983714 62028722 62043465 62046497 62075342 62075343 62075344 62106812 62106813 62109961 62109962 62114840 62119001…
FDA’s list runs to 3,321 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.
US Nationwide Distribution
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.
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 Jan 11, 2016.
- FDA classified it on Mar 12, 2016.
- FDA’s Enforcement Report published it on Mar 23, 2016.
- FDA terminated it on Apr 13, 2017.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Zimmer Manufacturing B.V., of Mercedita, PR.
- 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 3,321 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.