TIBIAL I/M NAIL 15MMDX26CM, TIBIAL I/M NAIL 15MMDX28CM TIBIAL I/M NAIL 15MMDX30CM TIBIAL I/M NAIL 14MMDX32CM…
Medical device recall Z-2597-2017. 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
- 1499 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?
TIBIAL I/M NAIL 15MMDX26CM, TIBIAL I/M NAIL 15MMDX28CM TIBIAL I/M NAIL 15MMDX30CM TIBIAL I/M NAIL 14MMDX32CM TIBIAL I/M NAIL 15MMDX32CM TIBIAL I/M NAIL 14MMDX34CM TIBIAL I/M NAIL 15MMDX34CM TIBIAL I/M NAIL 14MMDX36CM TIBIAL I/M NAIL 15MMDX36CM TIBIAL I/M NAIL 14MMDX38CM TIBIAL I/M NAIL 15MMDX38CM TIBIAL I/M NAIL 13MMDX40CM TIBIAL I/M NAIL 14MMDX40CM TIBIAL I/M NAIL 15MMDX40CM TIBIAL I/M NAIL 13MMDX42CM TIBIAL I/M NAIL 14MMDX42CM TIBIAL I/M NAIL 15MMDX42CM TIBIAL I/M NAIL 11MMDX44CM TIBIAL I/M NAIL 13MMDX44CM TIBIAL I/M NAIL 14MMDX44CM TIBIAL I/M NAIL 11MMDX46CM TIBIAL I/M NAIL 12MMDX46CM TIBIAL I/M NAIL 13MMDX46CM
1499, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Item Numbers: 00225326015 00225328015 00225330015 00225332014 00225332015 00225334014 00225334015 00225336014 00225336015 00225338014 00225338015 00225340013 00225340014 00225340015 00225342013 00225342014 00225342015 00225344011…
Every code shown here, 2,000 characters
Item Numbers: 00225326015 00225328015 00225330015 00225332014 00225332015 00225334014 00225334015 00225336014 00225336015 00225338014 00225338015 00225340013 00225340014 00225340015 00225342013 00225342014 00225342015 00225344011 00225344013 00225344014 00225346011 00225346012 00225346013 Lot Codes: 60689046 60689046R 60689048 60689048R 60541593 60541593R 60708943 60708943R 60733116 60733116R 60718442 60738224 60738224R 60747428 60541594 60759282 60759282R 60729914 60748950 60748950R 60750986 60750986R 60753362 60753362R 60837656 60837656R 60837650 60837657 60837657R 60837655 367894 60848473 367894R 60848473R 368331 60848488 60848488R 368105 368327 368105R 368327R 60848481 60848484 60848481R 60848484R 60858220 368330 368330R 368235 368395 60858225 368235R 368395R 60858225R 368428 368433 368403 368415 368422 368442 368403R 368415R 368422R 368442R 368394 368409 368410 368421 368429 368434 368437 368438 368439 368440 368441 60848485 368394R 368409R 368439R 368440R 368441R 60848485R 60858223 60933764 60973733 60973733R 60976652 60973738 60985622 60985622R 60985623 60985623R 60985624 60985625 60985625R 61040177 61040177R 61040179 60984603 61003748 61048029 61003748R 61040178 369111 61079864 61079864R 369093 369104 369116 369115 369113 369181 60973739 60973739R 61143370 61143370R 61188445 61170168 61170168R 61172763 61172763R 61187613 61187613R 61184356 61187623 61184356R 61187623R 61194163 61244786 61244786R 61277990 61277990R 61263725 61263726 61263725R 61267999 61277985 61277986 61277988 61277985R 61277986R 61285984 61276112 61277989 61285988 61307940 61315092 61315092R 61307938 61307942 61322926 61307942R 61322926R 61324290 61324291 61324291R 61327784 61327787 61327784R 61327787R 61298479 61327773 61327781 61327785 61327781R 61329351 61332785 61343281 61332786 61341150 61344241 61341150R 61344243 61351690 61351690R 369506 61382431 61382431R 61388034 61389804 61428542 369828 369856 369859 61441063 61458950 61458952 61468145 61490767 61475208 61523842 61621127 61641826…
FDA’s list runs to 2,566 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 2,566 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.