Hearth Record

Product 42 consists of all product under

Medical device recall Z-1140-2016. Published in FDA’s Enforcement Report on Mar 23, 2016.

FDA’s own record, on accessdata.fda.gov

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.

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.

Source:

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.

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Which ones are recalled?

Product 42 consists of all product under product code: HSB and same usage: Item no: 225224010 M/DN FEM IM NAIL 10MM DIA 225228010 M/DN FEM IM NAIL 10MM DIA 225230010 M/DN FEM IM NAIL 10MM DIA 225232010 M/DN FEM IM NAIL 10MM DIA 225234010 M/DN FEM IM NAIL 10MM DIA 225236010 M/DN FEM IM NAIL 10MM DIA 225238010 M/DN FEM IM NAIL 10MM DIA 225240010 M/DN FEM IM NAIL 10MM DIA 225242010 M/DN FEM IM NAIL 10MM DIA 225244010 M/DN FEM IM NAIL 10MM DIA 225246010 M/DN FEM IM NAIL 10MM DIA 225228011 M/DN FEM IM NAIL 11MM DIA 225230011 M/DN FEM IM NAIL 11MM DIA 225232011 M/DN FEM IM NAIL 11MM DIA 225234011 M/DN FEM IM NAIL 11MM DIA 225236011 M/DN FEM IM NAIL 11MM DIA 225238011 M/DN FEM IM NAIL 11MM DIA 225240011 M/DN FEM IM NAIL 11MM DIA 225242011 M/DN FEM IM NAIL 11MM DIA 225244011 M/DN FEM IM NAIL 11MM DIA 225246011 M/DN FEM IM NAIL 11MM DIA 225224012 M/DN FEM IM NAIL 12MM DIA 225232012 M/DN FEM IM NAIL 12MM DIA 225234012 M/DN FEM IM NAIL 12MM DIA 225236012 M/DN FEM IM NAIL 12MM DIA 225238012 M/DN FEM IM NAIL 12MM DIA 225240012 M/DN FEM IM NAIL 12MM DIA 225242012 M/DN FEM IM NAIL 12MM DIA 225244012 M/DN FEM IM NAIL 12MM DIA 225246012 M/DN FEM IM NAIL 12MM DIA 225228013 M/DN FEM IM NAIL 13MM DIA 225230013 M/DN FEM IM NAIL 13MM DIA 225232013 M/DN FEM IM NAIL 13MM DIA 225234013 M/DN FEM IM NAIL 13MM DIA 225236013 M/DN FEM IM NAIL 13MM DIA 225238013 M/DN FEM IM NAIL 13MM DIA 225240013 M/DN FEM IM NAIL 13MM DIA 225242013 M/DN FEM IM NAIL 13MM DIA 225244013 M/DN FEM IM NAIL 13MM DIA 225246013 M/DN FEM IM NAIL 13MM DIA 225236014 M/DN FEM IM NAIL 14MM DIA 225238014 M/DN FEM IM NAIL 14MM DIA 225240014 M/DN FEM IM NAIL 14MM DIA 225242014 M/DN FEM IM NAIL 14MM DIA 225244014 M/DN FEM IM NAIL 14MM DIA 225246014 M/DN FEM IM NAIL 14MM DIA 225234015 M/DN FEM IM NAIL 15MM DIA 225240015 M/DN FEM IM NAIL 15MM DIA 225242015 M/DN FEM IM NAIL 15MM DIA 225244015 M/DN FEM IM NAIL 15MM DIA 225242016 M/DN FEM IM NAIL 16MM DIA 225230008 M/DN FEM IM NAIL 8MM DIA 225232008 M/DN FEM IM NAIL 8MM DIA 225234008 M/DN FEM IM NAIL 8MM DIA 225238008 M/DN FEM IM NAIL 8MM DIA 225228009 M/DN FEM IM NAIL 9MM DIA 225230009 M/DN FEM IM NAIL 9MM DIA 225232009 M/DN FEM IM NAIL 9MM DIA 225234009 M/DN FEM IM NAIL 9MM DIA 225236009 M/DN FEM IM NAIL 9MM DIA 225238009 M/DN FEM IM NAIL 9MM DIA 225240009 M/DN FEM IM NAIL 9MM DIA 225242009 M/DN FEM IM NAIL 9MM DIA 225244009 M/DN FEM IM NAIL 9MM DIA 225418010 M/DN HUMERAL I/M NAIL 10M 225419510 M/DN HUMERAL I/M NAIL 10M 225421010 M/DN HUMERAL I/M NAIL 10M 225422510 M/DN HUMERAL I/M NAIL 10M 225424010 M/DN HUMERAL I/M NAIL 10M 225425510 M/DN HUMERAL I/M NAIL 10M 225427010 M/DN HUMERAL I/M NAIL 10M 225428510 M/DN HUMERAL I/M NAIL 10M 225430010 M/DN HUMERAL I/M NAIL 10M 225419511 M/DN HUMERAL I/M NAIL 11M 225421011 M/DN HUMERAL I/M NAIL 11M 225422511 M/DN HUMERAL I/M NAIL 11M 225424011 M/DN HUMERAL I/M NAIL 11M 225425511 M/DN HUMERAL I/M NAIL 11M 225427011 M/DN HUMERAL I/M NAIL 11M 225421012 M/DN HUMERAL I/M NAIL 12M 225422512 M/DN HUMERAL I/M NAIL 12M 225424012 M/DN HUMERAL I/M NAIL 12M 225425512 M/DN HUMERAL I/M NAIL 12M 225427012 M/DN HUMERAL I/M NAIL 12M 225428512 M/DN HUMERAL I/M NAIL 12M 225430012 M/DN HUMERAL I/M NAIL 12M 225418013 M/DN HUMERAL I/M NAIL 13M 225424013 M/DN HUMERAL I/M NAIL 13M 225427013 M/DN HUMERAL I/M NAIL 13M 225418006 M/DN HUMERAL I/M NAIL 6MM 225419506 M/DN HUMERAL I/M NAIL 6MM 225421006 M/DN HUMERAL I/M NAIL 6MM 225424006 M/DN HUMERAL I/M NAIL 6MM 225427006 M/DN HUMERAL I/M NAIL 6MM 225428506 M/DN HUMERAL I/M NAIL 6MM 225430006 M/DN HUMERAL I/M NAIL 6MM 225418007 M/DN HUMERAL I/M NAIL 7MM 225419507 M/DN HUMERAL I/M NAIL 7MM 225421007 M/DN HUMERAL I/M NAIL 7MM 225422507 M/DN HUMERAL I/M NAIL 7MM 225424007 M/DN HUMERAL I/M NAIL 7MM 225425507 M/DN HUMERAL I/M NAIL 7MM 225427007 M/DN HUMERAL I/M NAIL 7MM 225428507 M/DN HUMERAL I/M NAIL 7MM 225430007 M/DN HUMERAL I/M NAIL 7MM 225418008 M/DN HUMERAL I/M NAIL 8MM 225

1622, in FDA’s words.

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Codes to check against yours

lot no.: 370968 61880371 61914127 61996897 62268687 370510 61815337 61853647 61935534 61993296 62099313 62248255 62248257 62305229 370703 61801434 61801435 61827733 61832893 61889074 61889075 61897803 61897804 61897805 61897806 61897807…

Every code shown here, 2,000 characters

lot no.: 370968 61880371 61914127 61996897 62268687 370510 61815337 61853647 61935534 61993296 62099313 62248255 62248257 62305229 370703 61801434 61801435 61827733 61832893 61889074 61889075 61897803 61897804 61897805 61897806 61897807 61905777 61905788 61905791 61905793 61905855 61905856 61905857 61905858 61905859 61905860 61978492 62000674 62007971 62007972 62012314 62021552 62031759 62031760 62069152 62069153 370538 61815286 61815287 61815289 61827739 61827742 61827746 61853650 61869650 61869651 61869652 61869654 61869657 61869658 61869661 61869664 61869665 61869666 61869667 61869668 61869670 61869671 61869674 61914145 61914146 61914147 61935561 61958343 61958347 61979089 62001446 62012324 62012326 62017498 62017499 62021550 62062894 62062896 62062940 62062941 62062942 62062943 62062944 62062945 62062946 62063306 62063307 62063308 62063310 62063312 62063315 62063317 62063319 62063323 62063325 62099314 62099315 62140085 62206911 62206912 62206913 62206914 62206915 62206916 62206917 62206918 62206919 62206920 62206921 62206923 62206925 62268690 62293132 62299011 61914147R 61815301 61815303 61815305 61815306 61842709 61853661 61853663 61853665 61865666 61873539 61873540 61873541 61873542 61873543 61873545 61873546 61873547 61873548 61873549 61873552 61873553 61873554 61873555 61908125 61908133 61908136 61908137 61908138 61916605 61916608 61916609 61958349 61979093 61979094 61996878 62001449 62001450 62001451 62012320 62012321 62038950 62038951 62038952 62038953 62038954 62038955 62038956 62038957 62038958 62038959 62038960 62038961 62038962 62038963 62038964 62038966 62038967 62076535 62076536 62078721 62078722 62078723 62078724 62078725 62078726 62078727 62078728 62078729 62078731 62078733 62078734 62078736 62078737 62078739 62078740 62078741 62078742 62078743 62078744 62078745 62078746 62078747 62103747 62103809 62103810 62106370 62106372 62106373 62106375 62106376 62106377 62106379 62106380 62126764 62126765 62126766 62126767 62126768 62126769 62126770 62204387…

FDA’s list runs to 17,605 characters. The first part is shown; the rest is on FDA’s record.

Source:

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.

Source:

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.

Source:

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.
Source:

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.
Source:

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 17,605 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.
Source:

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.

Source:

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.

How to read a record

Four things every record does, shown on an example record made up for this guide.

An example record, made up for this guide

An example nursing home

Made up for this guide: no real place is shown

Not fully inspected in over two years (CMS flag)

11 health citations at the latest inspection cycle

The state average is 14.3.

Source:

CMS, State and US Averages and Health Deficiencies. Released Oct 28, 2026. Updated monthly.

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Every fact names its source.

Who published it, when, and how often it changes sit beside each fact, with a link to the agency’s own file.

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