Moore Hip Prosthesis Long Fenestrated Stem, several head Diameter, 203 mm Stem length
Medical device recall Z-1981-2013. Published in FDA’s Enforcement Report on Aug 28, 2013.
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 Aug 28, 2013. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 23 states named
- 1,710 units are in distribution 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 recently conducted a review of historic packaging validations completed. Based on this review, it was determined that a subset of product packaged at a single Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. This testing determined that a single packaging tray configuration, which
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Moore Hip Prosthesis Long Fenestrated Stem, several head Diameter, 203 mm Stem length. Used to seat the prosthesis with or without bone cement.
1,710 units are in distribution, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
25621400 203600 25711600 203800 25621300 25621500 203700 206500 26601000 60025547 25003900 60016485 60028037 60028040 60028041 60028042 60016492 60028045 60016487 60028036 60028038 60028039 60028043 60034329 60034330 60039203 60038245…
Every code shown here, 1,652 characters
25621400 203600 25711600 203800 25621300 25621500 203700 206500 26601000 60025547 25003900 60016485 60028037 60028040 60028041 60028042 60016492 60028045 60016487 60028036 60028038 60028039 60028043 60034329 60034330 60039203 60038245 60043146 60039161 60039170 60039173 25209700 60039184 60039186 60039201 60039207 60016491 60028044 60039214 60039217 60039218 60039220 60039222 60039223 60039224 60034328 60039158 60039199 60039216 223900 365036 365034 365037 60016497 60039221 60043147 60039166 60039168 60039182 60039183 60039209 60039219 60057784 60039213 60063014 60064868 60063150 60064885 60057785 60064862 60064867 60064886 60064888 60063042 60076067 60076073 60079812 60064887 60083643 60076089 60095965 60095967 60096024 60095966 60095988 60095986 60095978 60095989 60118708 365491 365488 365452 365495 365487 365455 365468 365460 365459 60096023 365469 365610 365470 365609 365476 365473 365483 365611 60187598 365608 60233503 366219 60278488 60293376 60301903 60301909 60301910 366367 366361 60293345 366362 366366 366371 366365 366359 366370 60335336 366368 60335394 366364 60331363 366369 366360 366440 60370153 366363 60323737 60441602 60459779 60501809 60506751 60553757 60532130 60609997 60610068 60506791 60717634 60717637 60717636 60750867 60750869 60823726 60834952 60845453 60933807 60940767 60979560 60990032 60659033 61199167 61496604 61501406 61582442 61582445 61582447 61582449 61582444 61599941 61496594 61658306 60750868 369883 61748928 61783682 61748929 61783684 61815823 61817989 61859934 61927043 61938355 61964729 62051548 62211964 62200345 62200346 62197219 62278696 62258850 62273053 62330362 62330364 62322473 62330365
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) including the states of CT, FL, GA, IL, IN, KS, KY, MA, MI, MN, MT, NC, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VI, and WI, and the countries of Singapore, Canada, Mexico, Arab Emirates, Saudi Arabia, and Hong Kong.
The states and territories these words name
23 states and territories.
Every one of them
- Connecticut
- Florida
- Georgia
- Illinois
- Indiana
- Kansas
- Kentucky
- Massachusetts
- Michigan
- Minnesota
- Montana
- North Carolina
- New Jersey
- New York
- Ohio
- Oregon
- Pennsylvania
- South Carolina
- Tennessee
- Texas
- Utah
- US Virgin Islands
- Wisconsin
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 Jul 16, 2013.
- FDA classified it on Aug 17, 2013.
- FDA’s Enforcement Report published it on Aug 28, 2013.
- FDA terminated it on Apr 30, 2015.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Zimmer, 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.