COMPRESSION SCREW
Medical device recall Z-1039-2014. 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?
COMPRESSION SCREW (1/2, 1-1/2, 1-1/4, 1-3/4, 1. 2. 3/4 IN)
7,044,680 total, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
60102586 60132471 60142537 60145090 60208438 60210902 60218747 60265332 60316667 60380272 60387522 60425078 60451935 60491775 60504962 60538423 60569271 60629869 60629870 60671868 60690620 60735901 60790633 60828403 60859841 60885052…
Every code shown here, 1,998 characters
60102586 60132471 60142537 60145090 60208438 60210902 60218747 60265332 60316667 60380272 60387522 60425078 60451935 60491775 60504962 60538423 60569271 60629869 60629870 60671868 60690620 60735901 60790633 60828403 60859841 60885052 60910023 60926381 60938165 60997341 61008512 61045578 61049489 61063879 61085581 61087377 61120002 61160484 61160485 61179531 61276833 61441956 61457387 61513903 61626104 61660625 61664773 61677697 61677702 61705589 61707801 61729145 61729146 61729745 61750828 62109253 60049193 60096554 60101711 60102587 60102588 60123238 60130244 60139604 60140249 60140250 60141583 60142539 60145093 60165156 60165157 60169713 60169714 60175619 60177171 60193845 60195824 60195825 60218748 60222629 60222631 60231265 60231266 60240376 60249923 60249924 60257490 60257491 60265333 60275014 60275015 60297515 60307915 60307916 60316668 60316669 60322678 60330555 60332252 60338176 60370097 60380274 60391503 60391504 60393274 60393275 60401261 60405226 60471147 60491776 60491777 60514747 60536910 60536915 60538424 60550151 60557766 60563823 60585131 60591894 60610147 60629871 60629873 60629876 60639748 60639754 60646706 60652934 60652937 60671869 60671870 60698228 60714739 60735902 60735903 60756001 60790637 60794404 60843741 60868448 60885053 60885055 60926383 60930495 60932378 60938166 60938167 60938168 60944479 60997342 60997343 61008514 61012474 61045579 61063880 61063881 61063882 61085583 61120003 61120004 61140029 61140030 61140031 61160486 61160487 61160488 61179533 61206340 61233884 61245938 61262515 61276834 61276835 61296488 61305259 61313619 61316547 61354692 61354693 61354694 61359714 61359715 61420257 61425119 61425120 61457388 61461974 61468652 61523661 61584920 61620163 61634702 61657584 61660646 61707798 61707799 61713678 61713679 61729746 61729747 61740684 61750832 62118597 62304910 60044879 60086616 60086618 60096556 60097892 60097893 60097894 60101712 60101713 60101714 60102590 60102594 60102595 60105526 60105527 60108360 60108362 60109554…
FDA’s list runs to 8,162 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 8,162 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.