HERBERT BONE SCREW, 3.0MM and HERBERT CANNULATED BONE S
Medical device recall Z-1038-2014. Published in FDA’s Enforcement Report on Feb 26, 2014.
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 Feb 26, 2014. 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
- 7,044,680 total 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 all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
HERBERT BONE SCREW, 3.0MM and HERBERT CANNULATED BONE S
7,044,680 total, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
60117014 60126278 60155287 60178897 60208414 60240381 60265317 60469641 60667003 60757014 60818325 60868434 60877876 60953936 61057493 61083223 61144260 61382948 61428496 61434453 60123231 60145083 60172484 60210898 60235186 60240382…
Every code shown here, 1,996 characters
60117014 60126278 60155287 60178897 60208414 60240381 60265317 60469641 60667003 60757014 60818325 60868434 60877876 60953936 61057493 61083223 61144260 61382948 61428496 61434453 60123231 60145083 60172484 60210898 60235186 60240382 60318917 60367391 60451947 60491785 60589767 60665682 60665683 60757015 60810891 60926378 60930484 60953937 60953938 61045584 61109124 61135014 61144262 61428498 61437196 60096548 60109535 60111962 60126279 60132072 60135124 60142531 60152397 60165150 60169711 60196507 60208415 60218735 60235187 60244038 60247673 60291570 60303879 60308478 60308479 60323219 60429155 60435646 60451952 60472779 60487172 60491786 60501138 60501139 60603149 60629958 60652968 60665904 60714756 60714757 60735916 60757016 60810892 60818328 60953942 61008526 61012463 61012464 61012465 61012466 61045586 61045587 61045588 61144264 61428502 61437198 61490670 61754462 60096549 60101706 60109537 60112829 60123232 60126280 60132073 60140244 60141574 60152398 60155288 60172485 60190827 60194301 60195422 60222272 60231258 60247674 60257483 60257484 60270650 60274974 60279001 60291572 60291574 60323220 60336408 60343703 60429156 60435650 60451953 60472780 60491790 60501140 60501141 60529889 60544298 60557791 60589768 60652972 60671883 60683409 60714758 60735917 60810894 60810895 60818329 60818330 60818331 60944477 60990430 61001693 61045590 61045591 61045592 61080404 61083225 61117670 61135015 61144266 61273769 61357130 61374874 61382949 61382950 61434454 61473777 61523647 369406 60096550 60101707 60109539 60112830 60117016 60126281 60130233 60132074 60140245 60141576 60148204 60152399 60155289 60162144 60169712 60172486 60178898 60189031 60190828 60194302 60195425 60228106 60235188 60244039 60247675 60253689 60257485 60270651 60274975 60279002 60291576 60291577 60303880 60308480 60323221 60336409 60343704 60372743 60380525 60425090 60429157 60435653 60451954 60472781 60478986 60501142 60501143 60529890 60544299 60544301 60557795 60652974 60667006 60675136 60677483…
FDA’s list runs to 10,500 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) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.
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.
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 Oct 11, 2013.
- FDA classified it on Feb 20, 2014.
- FDA’s Enforcement Report published it on Feb 26, 2014.
- FDA terminated it on Apr 14, 2017.
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.”
- FDA’s list of codes runs to 10,500 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
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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.