Product 67 consists of all product under
Medical device recall Z-1165-2016. 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
- 5013 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 67 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
5013, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
lot no.: 62012574 62076883 62082566 61866199 61874734 61893708 61899069 62022707 62028699 62030919 62042521 62051543 62060669 62075336 62079977 62079978 62079980 62113214 62114829 62114830 62122093 62128919 62128920 62132260 62140346…
Every code shown here, 1,998 characters
lot no.: 62012574 62076883 62082566 61866199 61874734 61893708 61899069 62022707 62028699 62030919 62042521 62051543 62060669 62075336 62079977 62079978 62079980 62113214 62114829 62114830 62122093 62128919 62128920 62132260 62140346 62148554 62160578 62163478 62188294 62222803 62222804 62223792 62240251 62240759 62240760 62246361 62246362 62246363 62258940 62260127 62261929 62261930 62284475 62284476 62314462 62317914 62320163 62327664 62330771 62331423 62340088 62354662 62354663 62360329 61823659 61832951 61866206 61866208 61873629 61881191 61886904 61889280 61890330 61891276 61896738 61901567 61901568 61952538 61953162 62010628 62027792 62028704 62028706 62028707 62035446 62042575 62050380 62051541 62051542 62058542 62060667 62060668 62079983 62079984 62097006 62097008 62103562 62103563 62103564 62122094 62122095 62122096 62125316 62127721 62127722 62128921 62128922 62132261 62132262 62137771 62137772 62137773 62143839 62143840 62148555 62154549 62154550 62154551 62160579 62163479 62181431 62181432 62181433 62194583 62206546 62222805 62222806 62223794 62227040 62227042 62240250 62240757 62240758 62246352 62246353 62246354 62246356 62246357 62246359 62246360 62256014 62256015 62262776 62262777 62264267 62264268 62267506 62268568 62278687 62278688 62278689 62281832 62291932 62291933 62291934 62298285 62298286 62299084 62305940 62315887 62315888 62317130 62317139 62317912 62317913 62320164 62327665 62328991 62328998 62328999 62329007 62329009 62333972 62333973 62333974 62333975 62340087 62346567 62346568 62346569 62346570 62352851 62352853 62360334 62362908 62362909 62362910 62362913 61843197 61878448 61881192 62012581 62030922 62082173 62140347 62151836 62256013 62262778 62284474 62303508 62325573 62340086 62354659 62354660 61815836 61870883 61876364 61878470 61881189 61882613 61884453 61901598 61977873 61977875 61977876 62024626 62024627 62024628 62036898 62038370 62042590 62050984 62050985 62058549 62065276 62073504 62073505 62094953 62094954 62094955 62094956…
FDA’s list runs to 2,689 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 2,689 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.