Product 49 consists of all product under
Medical device recall Z-1147-2016. 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
- 53338 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 49 consists of all product under product code: JWH and same usage: Item no: 597206529 NEXGEN ALL-POLY PATELLA, 597206532 NEXGEN ALL-POLY PATELLA, 597206535 NEXGEN ALL-POLY PATELLA, 597206538 NEXGEN ALL-POLY PATELLA, 597206541 NEXGEN ALL-POLY PATELLA, 598801713 NEXGEN CEMENTED STEM EXT 598801813 NEXGEN CEMENTED STEM EXT 598801913 NEXGEN CEMENTED STEM EXT 598801610 NEXGEN FLUTED STEM EXT, 1 598801611 NEXGEN FLUTED STEM EXT, 1 598801612 NEXGEN FLUTED STEM EXT, 1 598801613 NEXGEN FLUTED STEM EXT, 1 598801614 NEXGEN FLUTED STEM EXT, 1 598801615 NEXGEN FLUTED STEM EXT, 1 598801616 NEXGEN FLUTED STEM EXT, 1 598801618 NEXGEN FLUTED STEM EXT, 1 598801619 NEXGEN FLUTED STEM EXT, 1 598801620 NEXGEN FLUTED STEM EXT, 2 598801622 NEXGEN FLUTED STEM EXT, 2 598801624 NEXGEN FLUTED STEM EXT, 2 597206126 NEXGEN MICRO ALL-POLY PAT 597206129 NEXGEN MICRO ALL-POLY PAT 597206132 NEXGEN MICRO ALL-POLY PAT 597206135 NEXGEN MICRO ALL-POLY PAT for use in total knee arthroplasty
53338, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
lot no.: 61901117 61901118 61905924 61907317 61919774 61925086 61925087 61932224 61932230 61976473 61999384 61999385 61999386 61999389 61999392 61999397 61999398 62027343 62034454 62060787 62074474 62074475 62096756 62124173 62124175…
Every code shown here, 1,998 characters
lot no.: 61901117 61901118 61905924 61907317 61919774 61925086 61925087 61932224 61932230 61976473 61999384 61999385 61999386 61999389 61999392 61999397 61999398 62027343 62034454 62060787 62074474 62074475 62096756 62124173 62124175 62124176 62126603 62126604 62132121 62164944 62168501 62168504 62168505 62168506 62168507 62168509 62168510 62168511 62168512 62174922 62174923 62220941 62227159 62227166 62249275 62258601 62258607 62258618 62258623 62299435 62299436 62299440 62318771 62326940 62337816 62345677 62345678 62345679 62345680 62346195 62358017 62358018 62358019 62362896 62362897 62362898 62362899 62362900 62362902 62379320 62379321 62379322 62379323 62382825 62382827 62382828 62382829 62382830 62382831 62382832 62382833 62382834 62389197 62389199 62394741 62394742 62394743 62394744 62401077 62401079 62401890 62401892 61823947 61823948 61881528 61881531 61881532 61885110 61895826 61901109 61903389 61903390 61905927 61915687 61915688 61919777 61919778 61932241 61941690 61956251 61956252 61956253 61963006 61963010 61963011 61976477 61980333 61985178 61985180 61985181 61985183 61985184 61985186 61985187 61988469 61988474 61988475 61988476 61988478 61988479 61988483 61988484 61999434 61999435 61999436 61999437 61999438 61999441 62017865 62017866 62017867 62017870 62017871 62034471 62034472 62034474 62034480 62060790 62081115 62081128 62093754 62093758 62109782 62118612 62118614 62121748 62121751 62160772 62160780 62164931 62174918 62174919 62180204 62180205 62209028 62213330 62220924 62220927 62220936 62227148 62227150 62227153 62255832 62255836 62255838 62258568 62258569 62258570 62326932 62326937 62337794 62337799 62345664 62345665 62345666 62345669 62345670 62345671 62345672 62352427 62352428 62352429 62352430 62352432 62352434 62358010 62358011 62358012 62358013 62358014 62358015 62358016 62362882 62362883 62362884 62362885 62362886 62362887 62362888 62362889 62379317 62379318 62379319 62387312 62389187 62389188 62389189 62389190 62394734 62394736 62394738…
FDA’s list runs to 4,198 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 4,198 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.