Zimmer Segmental System Proximal Femoral Component 38mm Offset
Medical device recall Z-1381-2018. Published in FDA’s Enforcement Report on Apr 25, 2018.
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 Apr 25, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 38 states named
- 1,145 distribution events. Note that this product is lot controlled and may be distributed multiple times if it was returned and returned to the shelf 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?
There is a potential for debris in the hole on the superior lateral aspect of the device as a result of machining which may not have been adequately removed during the subsequent cleaning process.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Zimmer Segmental System Proximal Femoral Component 38mm Offset, Model Number 00-5850-030-38 The Segmental System is used for solving complex salvage cases to address patients with severe bone loss associated with disease, trauma, or revision.
1,145 distribution events. Note that this product is lot controlled and may be distributed multiple times if it was returned and returned to the shelf, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
11002427 11004885 11005449 11006334 11006335 11008928 61369868 61369869 61399454 61399456 61402368 61427788 61427789 61427790 61532231 61532232 61532233 61532234 61532235 61532236 61532237 61532238 61532239 61532241 61551139 61551140…
Every code shown here, 1,998 characters
11002427 11004885 11005449 11006334 11006335 11008928 61369868 61369869 61399454 61399456 61402368 61427788 61427789 61427790 61532231 61532232 61532233 61532234 61532235 61532236 61532237 61532238 61532239 61532241 61551139 61551140 61551141 61636762 61646779 61651745 61673447 61711591 61718216 61730528 61736057 61754485 61765397 61771371 61774299 61853520 61858613 61863256 61863257 61872494 61872495 61877127 61881912 61881913 61886497 61890895 61890896 61890897 61896238 61906572 61932477 61938143 61948661 61948662 61948663 61948664 61948665 61948666 61948667 61948668 61987706 61987707 61993688 61993689 62001043 62001044 62001045 62006906 62006907 62025413 62025414 62025415 62025416 62025417 62032847 62038122 62038123 62050139 62064439 62064441 62068642 62068643 62095951 62118361 62145857 62145858 62145859 62145860 62182529 62182530 62182532 62194346 62194347 62207101 62207102 62207103 62207104 62207105 62207106 62207107 62207108 62212766 62221039 62231040 62241457 62241458 62241459 62269612 62269614 62295471 62295472 62295476 62295478 62295484 62295485 62302621 62304625 62304626 62304629 62304631 62304633 62316980 62356881 62356882 62356883 62359406 62365604 62369067 62369068 62390693 62390695 62390696 62404124 62404134 62404135 62404136 62404137 62442828 62442830 62442831 62448185 62527059 62527060 62532955 62657082 62657084 62657086 62657087 62657088 62657103 62677055 62681448 62681449 62681450 62710734 62722215 62722216 62728198 62738894 62738915 62745181 62751153 62756795 62775210 62775213 62786919 62786920 62786921 62803589 62811462 62811466 62818960 62837956 62837957 62837958 62837959 62837967 62842869 62842872 62850837 62850839 62875912 62876080 62876081 62886654 62886655 62896686 62896689 62905096 62905097 62905289 62916319 62916323 62916325 62916326 62934308 62948025 62948026 62948027 62948028 62968876 62968877 62968878 62968879 63105972 63105973 63137777 63137782 63137783 63157479 63157481 63157484 63157486 63176981 63176982 63183367 63183368 63183369…
FDA’s list runs to 2,957 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.
Worldwide Distribution - USA (nationwide) to the states of : AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY., and to the countries of : Australia, South Korea, Malaysia, Netherlands, and Singapore.
The states and territories these words name
38 states and territories.
Every one of them
- Alabama
- Arizona
- California
- Colorado
- Connecticut
- Florida
- Georgia
- Iowa
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Michigan
- Minnesota
- Missouri
- Mississippi
- North Carolina
- Nebraska
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- South Carolina
- Tennessee
- Texas
- Utah
- Virginia
- Washington
- Wisconsin
- West Virginia
- Wyoming
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.
The words say it went outside the United States too.
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 Mar 29, 2018.
- FDA classified it on Apr 16, 2018.
- FDA’s Enforcement Report published it on Apr 25, 2018.
- FDA terminated it on Dec 17, 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 2,957 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.