ITST ANTI-ROTATION SCREW and FEM IM NAIL
Medical device recall Z-1013-2014. 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?
ITST ANTI-ROTATION SCREW and FEM IM NAIL (10MM, 11 MM, 12 MM, 13 MM, 14 MM and 15 MM) DIA X (18, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48 and 50)
7,044,680 total, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
60587172 60642426 60674247 60691374 60749915 60813568 60897964 60897965 60897966 60966659 60090438 60092202 60092203 60620584 60642427 60654140 60691390 60749916 60813570 60915915 60915916 60915917 60087121 60092204 60092205 60642428…
Every code shown here, 1,998 characters
60587172 60642426 60674247 60691374 60749915 60813568 60897964 60897965 60897966 60966659 60090438 60092202 60092203 60620584 60642427 60654140 60691390 60749916 60813570 60915915 60915916 60915917 60087121 60092204 60092205 60642428 60654141 60674248 60714649 60747680 60749917 60813572 60831102 60915929 60915930 60915931 60915932 60092206 60092207 60630503 60642429 60654142 60674249 60691392 60714651 60789796 60789797 60889685 60931200 61031022 61031023 60092208 60092209 60532938 60561134 60570051 60587174 60630504 60642430 60654144 60674250 60691399 60749918 60789811 60813573 60831103 60915853 60915859 60915881 60915882 60966668 61031028 61420306 61432404 60087123 60090440 60092210 60092211 60535276 60562837 60654146 60691414 60749919 60813595 60813596 60813597 60831104 60915940 60915943 61031024 61031025 61120332 61432405 60090442 60092212 60092213 60552204 60620589 60654147 60654148 60714654 60749920 60813598 60832686 60889687 60915918 60915919 60915921 61004060 61031029 61100833 61120333 60090443 60092215 60615944 60630505 60654149 60674251 60691416 60749921 60789807 60813599 60831105 60915884 60915885 60915887 61031027 61100835 60090444 60253827 60620591 60654151 60714656 60749922 60789794 60853697 60897968 60897969 60958487 60966666 60092220 60092221 60642432 60674252 60691436 60749923 60789793 60897961 60897962 60897963 60966667 60085615 60087126 60552203 60554585 60654153 60747681 60749924 60813601 60915937 60915938 60915939 60079503 60079505 60103543 60103544 60103545 60119931 60124048 60131328 60131329 60136433 60136434 60139743 60143336 60143337 60155221 60155222 60169687 60169688 60173964 60173966 60219063 60219064 60225895 60236611 60236621 60278602 60293977 60310068 60324201 60338316 60338317 60361131 60361132 60361133 60363705 60368193 60368194 60398160 60451902 60451903 60472738 60487398 60489887 60515451 60515452 60536773 60537997 60550819 60550820 60568228 60568231 60583769 60583771 60583772 60603370 60603371 60612896 60612897 60630467 60641825…
FDA’s list runs to 23,905 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 23,905 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.