HERBERT MINI BONE SCREW 2 and HERBERT/WHIPPLE C ANN BONE
Medical device recall Z-1002-2014. 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 MINI BONE SCREW 2 and HERBERT/WHIPPLE C ANN BONE. Items starting with 0011500 and 0011520.
7,044,680 total, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
60135114 60152390 60235174 60253671 60303868 60318915 60406045 60469637 60538425 60629952 60708626 60713650 60845570 60885012 61156076 61290771 60097888 60126180 60155283 60235175 60270647 60278995 60393280 60425089 60472771 60538426…
Every code shown here, 1,998 characters
60135114 60152390 60235174 60253671 60303868 60318915 60406045 60469637 60538425 60629952 60708626 60713650 60845570 60885012 61156076 61290771 60097888 60126180 60155283 60235175 60270647 60278995 60393280 60425089 60472771 60538426 60555772 60557775 60588046 60591903 60603145 60715075 60845571 60885014 61316528 61616158 61749182 60111959 60140238 60162141 60175614 60208384 60218727 60278996 60285802 60291544 60406046 60435612 60487168 60550156 60555773 60557774 60576766 60591904 60603146 60859714 60885015 61075639 61103192 61166254 61290772 61650519 61750812 60093352 60101703 60115126 60140239 60141562 60186799 60195341 60253673 60265299 60270648 60291547 60380281 60393281 60406047 60472772 60478980 60536890 60555774 60557776 60588047 60591905 60708627 60845573 60845574 60859715 61019223 61103193 61117518 61144243 61434451 61473776 61635184 61650520 61750818 60094821 60115127 60123222 60126182 60135115 60142528 60169707 60189030 60195345 60208386 60222271 60231248 60240379 60265301 60278998 60318916 60323216 60380282 60422419 60429154 60435617 60451941 60536891 60550158 60557777 60576768 60603147 60603150 60671881 60708628 60756056 60756071 60756072 60788112 60845575 60845576 60859716 60885016 61080555 61103194 61141227 61156079 61266929 61287003 61420555 61434452 61487520 61564719 61640830 61660576 61729755 61753841 60101704 60123223 60142529 60169708 60195352 60195392 60195393 60195394 60195395 60291561 60367373 60401265 60435620 60472773 60514749 60557778 60576769 60588048 60598747 60708630 60845577 60845578 60868431 61019224 61061013 61076451 61080556 61144244 61224620 61290773 61538664 61729756 62304810 60097889 60140240 60165147 60195353 60253674 60270649 60278999 60291562 60367380 60435623 60491779 60550161 60671882 60709315 60713651 60845579 60859730 61076452 61111263 61166257 61179536 61206335 61316530 61487522 61616159 60152391 60190823 60231245 60240380 60285801 60323217 60406048 60435626 60478981 60514751 60538427 60598749 60603151 60708631 60788113…
FDA’s list runs to 9,593 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 9,593 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.