Hearth Record

FEM IM NAIL 14MMDX30CM LEFT, FEM IM NAIL 14MMDX30CM RIGHT FEM IM NAIL 13MMDX32CM LEFT FEM IM NAIL 14MMDX32CM…

Medical device recall Z-2598-2017. Published in FDA’s Enforcement Report on Jun 21, 2017.

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 Jun 21, 2017. 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?

Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single package configuration due to packaging design verification test failures.

Source:

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

Which ones are recalled?

FEM IM NAIL 14MMDX30CM LEFT, FEM IM NAIL 14MMDX30CM RIGHT FEM IM NAIL 13MMDX32CM LEFT FEM IM NAIL 14MMDX32CM LEFT FEM IM NAIL 13MMDX32CM RIGHT FEM IM NAIL 14MMDX32CM RIGHT FEM IM NAIL 11MMDX34CM LEFT FEM IM NAIL 13MMDX34CM LEFT FEM IM NAIL 14MMDX34CM LEFT FEM IM NAIL 11MMDX34CM RIGHT FEM IM NAIL 13MMDX34CM RIGHT FEM IM NAIL 14MMDX34CM RIGHT FEM IM NAIL 11MMDX36CM LEFT FEM IM NAIL 12MMDX36CM LEFT FEM IM NAIL 13MMDX36CM LEFT FEM IM NAIL 14MMDX36CM LEFT FEM IM NAIL 11MMDX36CM RIGHT FEM IM NAIL 12MMDX36CM RIGHT FEM IM NAIL 13MMDX36CM RIGHT FEM IM NAIL 14MMDX36CM RIGHT FEM IM NAIL 10MMDX38CM LEFT FEM IM NAIL 11MMDX38CM LEFT FEM IM NAIL 12MMDX38CM LEFT FEM IM NAIL 13MMDX38CM LEFT FEM IM NAIL 14MMDX38CM LEFT FEM IM NAIL 10MMDX38CM RIGHT FEM IM NAIL 11MMDX38CM RIGHT FEM IM NAIL 12MMDX38CM RIGHT FEM IM NAIL 13MMDX38CM RIGHT FEM IM NAIL 14MMDX38CM RIGHT FEM IM NAIL 10MMDX40CM LEFT FEM IM NAIL 11MMDX40CM LEFT FEM IM NAIL 12MMDX40CM LEFT FEM IM NAIL 13MMDX40CM LEFT FEM IM NAIL 14MMDX40CM LEFT FEM IM NAIL 10MMDX40CM RIGHT FEM IM NAIL 11MMDX40CM RIGHT FEM IM NAIL 12MMDX40CM RIGHT FEM IM NAIL 13MMDX40CM RIGHT FEM IM NAIL 14MMDX40CM RIGHT FEM IM NAIL 10MMDX42CM LEFT FEM IM NAIL 11MMDX42CM LEFT FEM IM NAIL 12MMDX42CM LEFT FEM IM NAIL 13MMDX42CM LEFT FEM IM NAIL 14MMDX42CM LEFT FEM IM NAIL 10MMDX42CM RIGHT FEM IM NAIL 11MMDX42CM RIGHT FEM IM NAIL 12MMDX42CM RIGHT FEM IM NAIL 13MMDX42CM RIGHT FEM IM NAIL 14MMDX42CM RIGHT FEM IM NAIL 10MMDX44CM LEFT FEM IM NAIL 11MMDX44CM LEFT FEM IM NAIL 12MMDX44CM LEFT FEM IM NAIL 13MMDX44CM LEFT FEM IM NAIL 14MMDX44CM LEFT FEM IM NAIL 10MMDX44CM RIGHT FEM IM NAIL 11MMDX44CM RIGHT FEM IM NAIL 12MMDX44CM RIGHT FEM IM NAIL 13MMDX44CM RIGHT FEM IM NAIL 14MMDX44CM RIGHT FEM IM NAIL 10MMDX46CM LEFT FEM IM NAIL 11MMDX46CM LEFT FEM IM NAIL 12MMDX46CM LEFT FEM IM NAIL 13MMDX46CM LEFT FEM IM NAIL 14MMDX46CM LEFT FEM IM NAIL 10MMDX46CM RIGHT FEM IM NAIL 11MMDX46CM RIGHT FEM IM NAIL 12MMDX46CM RIGHT FEM IM NAIL 13MMDX46CM RIGHT FEM IM NAIL 14MMDX46CM RIGHT FEM IM NAIL 10MMDX48CM LEFT FEM IM NAIL 11MMDX48CM LEFT FEM IM NAIL 12MMDX48CM LEFT FEM IM NAIL 13MMDX48CM LEFT FEM IM NAIL 10MMDX48CM RIGHT FEM IM NAIL 11MMDX48CM RIGHT FEM IM NAIL 12MMDX48CM RIGHT FEM IM NAIL 13MMDX48CM RIGHT FEM IM NAIL 10MMDX50CM LEFT FEM IM NAIL 11MMDX50CM LEFT FEM IM NAIL 12MMDX50CM LEFT FEM IM NAIL 13MMDX50CM LEFT FEM IM NAIL 10MMDX50CM RIGHT FEM IM NAIL 11MMDX50CM RIGHT FEM IM NAIL 12MMDX50CM RIGHT FEM IM NAIL 13MMDX50CM RIGHT

24969, in FDA’s words.

Source:

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

Codes to check against yours

510K: K965098,K032367 Item Numbers: 00225730004 00225730014 00225732003 00225732004 00225732013 00225732014 00225734001 00225734003 00225734004 00225734011 00225734013 00225734014 00225736001 00225736002 00225736003 00225736004 00225736011…

Every code shown here, 2,000 characters

510K: K965098,K032367 Item Numbers: 00225730004 00225730014 00225732003 00225732004 00225732013 00225732014 00225734001 00225734003 00225734004 00225734011 00225734013 00225734014 00225736001 00225736002 00225736003 00225736004 00225736011 00225736012 00225736013 00225736014 00225738000 00225738001 00225738002 00225738003 00225738004 00225738010 00225738011 00225738012 00225738013 00225738014 00225740000 00225740001 00225740002 00225740003 00225740004 00225740010 00225740011 00225740012 00225740013 00225740014 00225742000 00225742001 00225742002 00225742003 00225742004 00225742010 00225742011 00225742012 00225742013 00225742014 00225744000 00225744001 00225744002 00225744003 00225744004 00225744010 00225744011 00225744012 00225744013 00225744014 00225746000 00225746001 00225746002 00225746003 00225746004 00225746010 00225746011 00225746012 00225746013 00225746014 00225748000 00225748001 00225748002 00225748003 00225748010 00225748011 00225748012 00225748013 00225750000 00225750001 00225750002 00225750003 00225750010 00225750011 00225750012 00225750013 Lot Numbers: 60667034 60667034R 60668410 60668410R 60598252 60654244 60671255 60654244R 60671255R 60654236 60684926 60684999 60654236R 60684926R 60684999R 60629337 60629337R 60691903 60691928 60691934 60691903R 60691928R 60691934R 60695640 60684996 60684996R 60671256 60671258 60691915 60695638 60671256R 60671258R 60691915R 60695638R 60691893 60691901 60691909 60691911 60695628 60691901R 60691909R 60691911R 60695628R 367281 367297 60693123 60695646 60711202 60713644 367281R 367297R 60693123R 60695646R 60711202R 60713644R 60691907 60691913 60691935 60715185 60715189 60718446 60719890 60691907R 60691935R 60715185R 60715189R 60718446R 60719890R 60691906 60691910 60695619 60695620 60708944 60691906R 60691910R 60695619R 60695620R 60708944R 60695631 60715178 60715182 60715188 60695631R 60715178R 60715182R 60715188R 60691908 60715186 60691908R 60715186R 60691912 60691914 60691912R 60691914R 60715181 60715183 60718445 60718448…

FDA’s list runs to 15,590 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.

Domestic: Puerto Rico, AK AL AR AZ CA CO CT FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA RI SC SD TN TX UT VA VT WA WI WV WY Foreign: CANADA, ALGERIA ARGENTINA AUSTRALIA BELGIUM BRAZIL BRIDGEND WALES CHINA DUBAI UAE EGYPT EL SALVADOR ENGLAND ESCHBACH GERMANY EXPORT DORAL FL FRANCE GERMANY GUATEMALA HONDURAS INDIA ITALY JAMAICA JAPAN JORDAN KOREA LEBANON DELIVERY SERVICE (LYNBROOK NY) MALAYSIA MEXICO MIAMI FL MOROCCO NETHERLANDS NEW ZEALAND NICARAGUA PANAMA PERU PHARR TEXAS POLAND PUERTO RICO RIO DE JANEIRO SAUDI ARABIA SINGAPORE SPAIN SWITZERLAND TAIWAN THAILAND THE NETHERLANDS TRIPOLI UK VIRGIN ISLANDS VA/DOD: Both see addresses below

The states and territories these words name

49 states and territories.

Every one of them
  • Alaska
  • Alabama
  • Arkansas
  • Arizona
  • California
  • Colorado
  • Connecticut
  • Florida
  • Georgia
  • Hawaii
  • Iowa
  • Idaho
  • Illinois
  • Indiana
  • Kansas
  • Kentucky
  • Louisiana
  • Massachusetts
  • Maryland
  • Maine
  • Michigan
  • Minnesota
  • Missouri
  • Mississippi
  • Montana
  • North Carolina
  • North Dakota
  • Nebraska
  • New Hampshire
  • New Jersey
  • New Mexico
  • Nevada
  • New York
  • Ohio
  • Oklahoma
  • Oregon
  • Pennsylvania
  • Rhode Island
  • South Carolina
  • South Dakota
  • Tennessee
  • Texas
  • Utah
  • Virginia
  • Vermont
  • Washington
  • Wisconsin
  • West Virginia
  • Wyoming

The words say it went outside the United States too.

Source:

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

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 Apr 28, 2017.
  • FDA classified it on Jun 15, 2017.
  • FDA’s Enforcement Report published it on Jun 21, 2017.
  • FDA terminated it on May 15, 2019.
Source:

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

Who is recalling it?

  • Zimmer Biomet, Inc., of Warsaw, IN.
  • 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 15,590 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.

From the homeNone yet. Replies and paid listings aren’t open, and when they open they will sit here, below the record.

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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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