FEM IM NAIL 15MMDX30CM, FEM IM NAIL 16MMDX30CM FEM IM NAIL 14MMDX32CM FEM IM NAIL 15MMDX32CM FEM IM NAIL…
Medical device recall Z-2596-2017. Published in FDA’s Enforcement Report on Jun 21, 2017.
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.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 49 states named in where it went
- 27279 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?
Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single package configuration due to packaging design verification test failures.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
FEM IM NAIL 15MMDX30CM, FEM IM NAIL 16MMDX30CM FEM IM NAIL 14MMDX32CM FEM IM NAIL 15MMDX32CM FEM IM NAIL 16MMDX32CM FEM IM NAIL 14MMDX34CM FEM IM NAIL 15MMDX34CM FEM IM NAIL 16MMDX34CM FEM IM NAIL 14MMDX36CM FEM IM NAIL 15MMDX36CM FEM IM NAIL 14MMDX38CM FEM IM NAIL 15MMDX38CM FEM IM NAIL 11MMDX40CM FEM IM NAIL 13MMDX40CM FEM IM NAIL 14MMDX40CM FEM IM NAIL 15MMDX40CM FEM IM NAIL 11MMDX42CM FEM IM NAIL 12MMDX42CM FEM IM NAIL 13MMDX42CM FEM IM NAIL 14MMDX42CM FEM IM NAIL 15MMDX42CM FEM IM NAIL 11MMDX44CM FEM IM NAIL 12MMDX44CM FEM IM NAIL 13MMDX44CM FEM IM NAIL 14MMDX44CM FEM IM NAIL 10MMDX46CM FEM IM NAIL 11MMDX46CM FEM IM NAIL 12MMDX46CM FEM IM NAIL 13MMDX46CM FEM IM NAIL 14MMDX46CM FEM IM NAIL 10MMDX48CM FEM IM NAIL 11MMDX48CM FEM IM NAIL 12MMDX48CM FEM IM NAIL 13MMDX48CM FEM IM NAIL 14MMDX48CM FEM IM NAIL 13MMDX50CM FEM IM NAIL 14MMDX50CM
27279, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Item Numbers: 00225230015 00225230016 00225232014 00225232015 00225232016 00225234014 00225234015 00225234016 00225236014 00225236015 00225238014 00225238015 00225240011 00225240013 00225240014 00225240015 00225242011 00225242012…
Every code shown here, 1,993 characters
Item Numbers: 00225230015 00225230016 00225232014 00225232015 00225232016 00225234014 00225234015 00225234016 00225236014 00225236015 00225238014 00225238015 00225240011 00225240013 00225240014 00225240015 00225242011 00225242012 00225242013 00225242014 00225242015 00225244011 00225244012 00225244013 00225244014 00225246010 00225246011 00225246012 00225246013 00225246014 00225248010 00225248011 00225248012 00225248013 00225248014 00225250013 00225250014 Lot Numbers: 60684923 60680624 60680627 60680627R 60680623 60680623R 60680629 60680629R 60680615 60680628 60680615R 60680628R 60680625 60680619 60680619R 60691710 60691708 60691713 60691708R 60732923 60732923R 60691711 60732925 60745751 60691711R 60745751R 60732924 60747393 60747393R 367355 60753357 367355R 60753357R 60721966 60747408 60721966R 367348 60751917 60751917R 60753355 60753356 60758098 60753355R 60715104 60758099 60735584 60735585 60735585R 367352 60789431 60789432 60789431R 367354 60747405 60797046 60797046R 60789429 60789429R 60691709 60789426 60789428 60691709R 60807362 60807365 60807366 60807376 60807376R 60807359 60817729 60817730 60817731 60817733 60817730R 60817733R 367739 367739R 367737 60817725 60817727 367737R 60817727R 60822101 60822112 60822112R 60821407 60822113 60821407R 367749 367749R 60822105 60822106 60822107 60822106R 60822107R 60822102 60822102R 60821408 60827839 60827840 60827839R 60827840R 60836675 367751 60828364 367750 367752 60836673 367750R 367766 367767 367779 367766R 60836664 60836664R 60828363 60833614 60833960 60836676 60838315 60838317 60843576 60833614R 60838315R 60843576R 60833622 60843575 60827843 60833609 60836659 60836670 60836679 60836680 60838316 60827843R 60836659R 367753 60827844 60828362 60830568 60843574 60844203 60844204 60848502 367753R 60827844R 60844203R 60844204R 60848502R 60829849 60838314 60848496 60848497 60848504 60848497R 60836677 60848508 60854060 60836677R 60848508R 60854049 367781 60854056 60854057 60854056R 60854057R 60854050 60854061 60854061R…
FDA’s list runs to 11,173 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.
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.
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.
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.
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.
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 11,173 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.