Product 51 consists of all product under
Medical device recall Z-1149-2016. 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
- 29525 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 51 consists of all product under product code: JWH and same usage: Item no: 598603701 NEXGEN OPTION STEMMED TIB 598603702 NEXGEN OPTION STEMMED TIB 598604701 NEXGEN OPTION STEMMED TIB 598604702 NEXGEN OPTION STEMMED TIB 598605701 NEXGEN OPTION STEMMED TIB 598605702 NEXGEN OPTION STEMMED TIB for use in total knee arthroplasty
29525, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
lot no.: 61627858 61667594 61687053 61687057 61711627 61711636 61711638 61711640 61711642 61787558 61787559 61787560 61787561 61787562 61791460 61791462 61791464 61791466 61791467 61791468 61797925 61797926 61797927 61797928 61797929…
Every code shown here, 1,998 characters
lot no.: 61627858 61667594 61687053 61687057 61711627 61711636 61711638 61711640 61711642 61787558 61787559 61787560 61787561 61787562 61791460 61791462 61791464 61791466 61791467 61791468 61797925 61797926 61797927 61797928 61797929 61797930 61797931 61797932 61797933 61809215 61809216 61809217 61809218 61809219 61816553 61820496 61820497 61820498 61823244 61823245 61823246 61823247 61823248 61829314 61829315 61829316 61829317 61829318 61838186 61838187 61838188 61838189 61838190 61850512 61850513 61850515 61850516 61850517 61861391 61861392 61861393 61861394 61861395 61865095 61865096 61865097 61865098 61870089 61870090 61870091 61870092 61875986 61875987 61875988 61875989 61875990 61879452 61879453 61879454 61890348 61890349 61890350 61890351 61890352 61890353 61898708 61898709 61898710 61898711 61907203 61907204 61907206 61907207 61907208 61907210 61919431 61919432 61919437 61919439 61919442 61919443 61925054 61925055 61925056 61925057 61925058 61925059 61925060 61926866 61926867 61926868 61926869 61926870 61936965 61936966 61936967 61936968 61936969 61940695 61940696 61940697 61940698 61940699 61952663 61952664 61952665 61952666 61952667 61962903 61962904 61962905 61962906 61962907 61969272 61969273 61969274 61969275 61969276 61979874 61979875 61979876 61979877 61984968 61984969 61984970 61984971 61996251 61996252 61996253 61996254 61996255 61996256 61996257 62005997 62005998 62005999 62006000 62006001 62006002 62006003 62006004 62006005 62011711 62011712 62011713 62011714 62011715 62011716 62018183 62018184 62018185 62022090 62022091 62022092 62025944 62025945 62025946 62025947 62037053 62037054 62037055 62037056 62037887 62037888 62037889 62049124 62049125 62049126 62082044 62082045 62082046 62082047 62082048 62095801 62095802 62095803 62095804 62095805 62102707 62102708 62102709 62102710 62102716 62112547 62112548 62112549 62112550 62126220 62126221 62126222 62130086 62130087 62133489 62143589 62143590 62143591 62156831 62156832 62156833 62156834 62170372…
FDA’s list runs to 11,373 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 11,373 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
-
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.