Product 27 consists of all product under
Medical device recall Z-1125-2016. Published in FDA’s Enforcement Report on Mar 23, 2016.
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 Mar 23, 2016. 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
- 945 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?
As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. The affected products are sterile.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Product 27 consists of all product under product code: HSB and same usage: Item no: 234703104 DISTAL MEDIAL FEMORAL CON 234703206 DISTAL MEDIAL FEMORAL CON 234703208 DISTAL MEDIAL FEMORAL CON 234800504 DISTAL POSTERIOR/LATERAL 234800506 DISTAL POSTERIOR/LATERAL 234800508 DISTAL POSTERIOR/LATERAL 234800510 DISTAL POSTERIOR/LATERAL 234800604 DISTAL POSTERIOR/LATERAL 234800606 DISTAL POSTERIOR/LATERAL 234800608 DISTAL POSTERIOR/LATERAL 234800610 DISTAL POSTERIOR/LATERAL 234800614 DISTAL POSTERIOR/LATERAL Product Usage: An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.
945, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
lot no.: 61809193 61809203 61809206 61822572 61841518 61844443 61897681 61901015 62001246 62193768 62277477 62277478 62330721 62336479 62345698 62193768N 62277478N 62266680 61880656 62234613 62266684 62266688 62266692 62333353 61622044…
Every code shown here, 1,996 characters
lot no.: 61809193 61809203 61809206 61822572 61841518 61844443 61897681 61901015 62001246 62193768 62277477 62277478 62330721 62336479 62345698 62193768N 62277478N 62266680 61880656 62234613 62266684 62266688 62266692 62333353 61622044 62339493 62339495 62330722 61635839 62330724 61782888 61782889 61782891 61809172 61809173 61809184 61822578 61830206 61830207 61830208 61830209 61838593 61838596 61838599 61838602 61838603 61838604 61864057 61867128 61867129 61893770 61893771 61893772 61901018 61934345 61934352 61951304 61951305 61951306 61996677 62001247 62001248 62001249 62043075 62124382 62124383 62124384 62124385 62124386 62140004 62140005 62167136 62167137 62167139 62167140 62172551 62172553 62175521 62175523 62266672 62266673 62266674 62266675 62277480 62277481 62277482 62299139 62299140 62299143 62299146 62299147 62299148 62314147 62314150 62314154 62314158 62336480 62336481 62277480N 62277481N 62299140N 62299147N 62266682 62266686 61880383 62266690 61880385 62266695 62294804 62266697 62299159 62137496 62148988 62158959 62294778 62259834 62284876 62294792 61634097 62259848 62294786 62280715 62330723 62285471 62285470 61801384 61801385 61801389 61822581 61841519 61901019 61996680 61996681 62181505 62181510 62225836 62266670 62266671 62277483 62306208 62311817 62311818 62336483 62336484 62306208N 61809209 61864058 61880655 61939421 62266676 62311819 62336485 62333354 61793329 61939423 61690423 61695534 61777525 61777526 61782870 61782872 61782874 61782876 61782878 61804353 61804354 61804355 61804356 61804357 61804358 61804359 61819365 61819366 61819369 61822544 61822547 61825926 61825927 61825932 61825935 61825936 61825939 61835597 61835598 61835599 61835600 61841520 61841521 61841522 61841523 61844441 61844459 61844460 61852150 61852151 61852153 61852154 61856841 61856844 61867113 61867114 61867115 61867116 61875012 61875013 61875014 61875015 61880647 61880648 61886705 61886708 61886711 61886712 61897683 61897685 61901005 61901006 61901008 61901009 61908425…
FDA’s list runs to 5,425 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.
US Nationwide Distribution
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 Jan 11, 2016.
- FDA classified it on Mar 12, 2016.
- FDA’s Enforcement Report published it on Mar 23, 2016.
- FDA terminated it on Apr 13, 2017.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Zimmer Manufacturing B.V., of Mercedita, PR.
- 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 5,425 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.