Product 53 consists of all product under
Medical device recall Z-1151-2016. 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
- 202221 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 53 consists of all product under: product code: JWH and same usage: Item no: 597002501 NEXGEN PRECOAT PEG TIB PL 597002502 NEXGEN PRECOAT PEG TIB PL 597003501 NEXGEN PRECOAT PEG TIB PL 597003502 NEXGEN PRECOAT PEG TIB PL 597004501 NEXGEN PRECOAT PEG TIB PL 597004502 NEXGEN PRECOAT PEG TIB PL 597005501 NEXGEN PRECOAT PEG TIB PL 597005502 NEXGEN PRECOAT PEG TIB PL 597005503 NEXGEN PRECOAT PEG TIB PL 597005504 NEXGEN PRECOAT PEG TIB PL 598002701 NEXGEN PRECOAT STEMMED TI 598002702 NEXGEN PRECOAT STEMMED TI 598003701 NEXGEN PRECOAT STEMMED TI 598003702 NEXGEN PRECOAT STEMMED TI 598004701 NEXGEN PRECOAT STEMMED TI 598004702 NEXGEN PRECOAT STEMMED TI 598005701 NEXGEN PRECOAT STEMMED TI 598005702 NEXGEN PRECOAT STEMMED TI 598005703 NEXGEN PRECOAT STEMMED TI 598005704 NEXGEN PRECOAT STEMMED TI 598801510 NEXGEN SHARP FLUTED STEM 598801511 NEXGEN SHARP FLUTED STEM 598801512 NEXGEN SHARP FLUTED STEM 598801513 NEXGEN SHARP FLUTED STEM 598801514 NEXGEN SHARP FLUTED STEM 598801515 NEXGEN SHARP FLUTED STEM 598801516 NEXGEN SHARP FLUTED STEM 598801517 NEXGEN SHARP FLUTED STEM 598801518 NEXGEN SHARP FLUTED STEM 598801519 NEXGEN SHARP FLUTED STEM 598801520 NEXGEN SHARP FLUTED STEM 598801010 NEXGEN STRAIGHT STEM EXT 598801011 NEXGEN STRAIGHT STEM EXT 598801012 NEXGEN STRAIGHT STEM EXT 598801013 NEXGEN STRAIGHT STEM EXT 598801014 NEXGEN STRAIGHT STEM EXT 598801015 NEXGEN STRAIGHT STEM EXT 598801016 NEXGEN STRAIGHT STEM EXT 598801017 NEXGEN STRAIGHT STEM EXT 598801018 NEXGEN STRAIGHT STEM EXT 598801020 NEXGEN STRAIGHT STEM EXT 598801022 NEXGEN STRAIGHT STEM EXT 598801024 NEXGEN STRAIGHT STEM EXT 598801112 NEXGEN STRAIGHT STEM EXT 598801113 NEXGEN STRAIGHT STEM EXT 598801114 NEXGEN STRAIGHT STEM EXT 598801115 NEXGEN STRAIGHT STEM EXT 598801116 NEXGEN STRAIGHT STEM EXT 598801117 NEXGEN STRAIGHT STEM EXT 598801118 NEXGEN STRAIGHT STEM EXT 598801212 NEXGEN STRAIGHT STEM EXT 598801215 NEXGEN STRAIGHT STEM EXT for use in total knee arthroplasty
202221, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
lot no.: 61797104 61797098 61797099 61823441 61958847 61963895 62029932 62029933 62130571 62130703 62190529 62261995 62261996 62298547 61809090 61809091 61809092 61809094 61809095 61816526 61816527 61816528 61816529 61823442 61823443…
Every code shown here, 1,998 characters
lot no.: 61797104 61797098 61797099 61823441 61958847 61963895 62029932 62029933 62130571 62130703 62190529 62261995 62261996 62298547 61809090 61809091 61809092 61809094 61809095 61816526 61816527 61816528 61816529 61823442 61823443 61830085 61830086 61830087 61869782 61869783 61869784 61905813 61905814 61905815 61905816 61918789 61926794 61926795 61926796 61947456 61947457 61947458 61967928 61967929 61984965 61984966 61984967 62051520 62082119 62082120 62082121 62098807 62115643 62115644 62115645 62130131 62159766 62159767 62159768 62168172 62177114 62189275 62189276 62189277 62189278 62189279 62214676 62214677 62214678 62215101 62215102 62292591 62292592 62292593 62326317 62332106 62337925 62337926 61760954 61809099 61809101 61816531 61816532 61823445 61823446 61830088 61830089 61830090 61869785 61869786 61869787 61869788 61905817 61905818 61918790 61918791 61918792 61947464 61947465 61967930 61967931 61984957 61984958 62029934 62041310 62051521 62051522 62082122 62082123 62115646 62115647 62115648 62141264 62141265 62168173 62177115 62190520 62200274 62200275 62200276 62214679 62214680 62298548 62298549 62337928 62345194 61605870 61672547 61672548 61760960 61760961 61808305 61808306 61808308 61808310 61816481 61816482 61816483 61816484 61816485 61823427 61823428 61823429 61871288 61871289 61871290 61900655 61900656 61918793 61926784 61926785 61926786 61935104 61935105 61935106 61947471 61947473 61947474 61967932 61967933 61967934 61984959 61984960 61984961 62051517 62051518 62080355 62080356 62080357 62130201 62130202 62130203 62130204 62168168 62168169 62168170 62168171 62200269 62200270 62200271 62200272 62227409 62227410 62227411 62261983 62261984 62261985 62298545 62298546 62332110 62332111 61760955 61760956 61809104 61809105 61816534 61823448 61823449 61830091 61830092 61871292 61871293 61918794 61926787 61926788 61926789 61926790 61947477 61947478 61967935 61984962 61984963 62041311 62098808 62098809 62098810 62159763 62159764 62159765 62168174 62190522…
FDA’s list runs to 64,787 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 64,787 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.