Product 54 consists of all product under
Medical device recall Z-1152-2016. 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
- 1767 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 54 consists of all product under product code: JWH and same usage: Item no: 596009900 NEXGEN TAPER PLUG for use in total knee arthroplasty
1767, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
lot no.: 61390872 61761213 61780493 61780494 61780495 61780496 61780497 61789111 61789112 61789113 61789114 61789115 61789116 61789117 61789118 61789119 61789120 61789121 61789122 61789123 61789124 61789125 61789126 61789127 61789128…
Every code shown here, 1,998 characters
lot no.: 61390872 61761213 61780493 61780494 61780495 61780496 61780497 61789111 61789112 61789113 61789114 61789115 61789116 61789117 61789118 61789119 61789120 61789121 61789122 61789123 61789124 61789125 61789126 61789127 61789128 61789129 61789130 61789131 61789132 61789133 61789134 61789135 61789136 61789137 61789138 61789139 61789140 61789141 61789142 61798737 61798738 61798739 61798740 61798741 61798742 61798743 61798744 61798745 61798746 61799383 61799384 61799385 61799386 61799387 61799388 61799389 61799390 61799391 61799392 61803606 61803607 61803608 61803609 61803610 61803611 61803612 61803613 61803614 61803615 61807320 61807321 61807322 61807323 61807324 61807325 61807326 61807327 61807328 61807329 61807330 61809795 61809796 61809797 61809798 61809799 61809801 61809802 61809803 61809804 61809805 61816959 61816960 61816961 61816962 61816963 61816964 61816965 61816966 61816967 61816968 61816969 61816970 61816971 61816972 61816973 61816974 61816975 61821036 61821037 61821038 61821039 61821040 61821041 61821042 61821043 61821044 61821645 61821646 61821647 61821648 61821649 61821650 61821651 61821652 61821653 61821654 61821655 61821656 61824212 61824213 61824214 61824215 61824218 61824219 61824220 61824221 61824222 61824223 61824224 61824225 61824226 61841214 61841215 61841216 61841217 61841218 61841219 61841220 61841221 61841222 61841223 61841224 61841225 61841226 61841227 61841228 61853071 61853072 61853073 61853074 61853075 61853076 61853077 61853078 61853079 61853080 61854884 61854885 61854886 61854887 61854888 61854889 61854890 61854891 61854892 61854893 61854895 61854896 61854897 61854898 61854899 61854901 61854902 61854903 61854904 61854908 61859266 61859267 61859268 61859269 61859270 61859271 61859272 61859273 61859274 61859275 61859276 61859277 61859278 61859279 61859280 61861407 61861408 61861409 61861410 61861411 61861412 61861413 61861414 61861415 61861416 61861417 61861418 61862838 61862839 61862840 61862841 61862842 61862843 61862844 61862845…
FDA’s list runs to 11,546 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 11,546 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.