Cephalomedullary Nail (CMN), Various sizes
Medical device recall Z-0337-2020. Published in FDA’s Enforcement Report on Nov 13, 2019.
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 Nov 13, 2019. 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
- 5,459,583 total devices 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?
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Cephalomedullary Nail (CMN), Various sizes, Item Nos. 47249318009 47249318010 47249318011 47249318013 47249318014 47249318109 47249318110 47249318111 47249318113 47249318114 47249318209 47249318210 47249318211 47249318213 47249318214 47249318309 47249318310 47249318311 47249318313 47249318314 47249321010 47249321011 47249321013 47249321014 47249321110 47249321111 47249321113 47249321114 47249321210 47249321211 47249321213 47249321214 47249321310 47249321311 47249321313 47249321314 47249321410 47249321411 47249321413 47249321414 47249321510 47249321511 47249321513 47249321514 47249330010 47249330011 47249330013 47249330110 47249330111 47249330113 47249330210 47249330211 47249330213 47249330310 47249330311 47249330313 47249330410 47249330411 47249330413 47249330510 47249330511 47249330513 47249332010 47249332011 47249332013 47249332110 47249332111 47249332113 47249332210 47249332211 47249332213 47249332310 47249332311 47249332313 47249332410 47249332411 47249332413 47249332510 47249332511 47249332513 47249334010 47249334011 47249334013 47249334110 47249334111 47249334113 47249334210 47249334211 47249334213 47249334310 47249334311 47249334313 47249334410 47249334411 47249334413 47249334510 47249334511 47249334513 47249336010 47249336011 47249336013 47249336110 47249336111 47249336113 47249336210 47249336211 47249336213 47249336310 47249336311 47249336313 47249336410 47249336411 47249336413 47249336510 47249336511 47249336513 47249338010 47249338011 47249338013 47249338110 47249338111 47249338113 47249338210 47249338211 47249338213 47249338310 47249338311 47249338313 47249338410 47249338411 47249338413 47249338510 47249338511 47249338513 47249340010 47249340011 47249340013 47249340110 47249340111 47249340113 47249340210 47249340211 47249340213 47249340310 47249340311 47249340313 47249340410 47249340411 47249340413 47249340510 47249340511 47249340513 47249342010 47249342011 47249342013 47249342110 47249342111 47249342113 47249342210 47249342211 47249342213 47249342310 47249342311 47249342313 47249342410 47249342411 47249342413 47249342510 47249342511 47249342513 47249344010 47249344011 47249344013 47249344110 47249344111 47249344113 47249344210 47249344211 47249344213 47249344310 47249344311 47249344313 47249344410 47249344411 47249344413 47249344510 47249344511 47249344513 47249346010 47249346011 47249346013 47249346110 47249346111 47249346113 47249346210 47249346211 47249346213 47249346310 47249346311 47249346313 47249346410 47249346411 47249346413 47249346510 47249346511 47249346513 47249348010 47249348011 47249348013 47249348110 47249348111 47249348113 47249348210 47249348211 47249348213 47249348310 47249348311 47249348313 47249348410 47249348411 47249348413 47249348510 47249348511 47249348513
5,459,583 total devices, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
All products manufactured prior to January 2014.
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.
Distributed nationwide.
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 Oct 10, 2019.
- FDA classified it on Nov 7, 2019.
- FDA’s Enforcement Report published it on Nov 13, 2019.
- FDA terminated it on May 19, 2020.
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.”
- 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.