VERSA-FX FEMORAL FIXATION SYSTEM COMPRESSION LAG SCREW, several length
Medical device recall Z-2092-2013. Published in FDA’s Enforcement Report on Sep 4, 2013.
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 Sep 4, 2013. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 2 states named
- 85, 794 units in 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?
Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak test compromising the sterility of the product.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
VERSA-FX FEMORAL FIXATION SYSTEM COMPRESSION LAG SCREW, several length (55 mm to 155 mm), diameters (12.7 mm and 15.8 mm) and short thread, standard thread and large thread. Item codes starting with 00-1193-005, 00-1193-010 and 00-1193-015. orthopedic implant.
85, 794 units in total, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
60550146 60585234 60585240 60621358 60612822 60585235 60612824 60585239 60629949 60629951 60573157 60612823 60612832 60629948 60629756 60629755 60629950 60560744 60621346 60621347 60621348 60621350 60612826 60621349 60621351 60621353…
Every code shown here, 1,998 characters
60550146 60585234 60585240 60621358 60612822 60585235 60612824 60585239 60629949 60629951 60573157 60612823 60612832 60629948 60629756 60629755 60629950 60560744 60621346 60621347 60621348 60621350 60612826 60621349 60621351 60621353 60585244 60612820 60612830 60621354 60621356 60621357 60612825 60612829 60612831 60653083 60653092 60653075 60653078 60653085 60653088 60653100 60653111 60539408 60539409 60653095 60653098 60653107 60653110 60653114 60653116 60653115 60653121 60671979 60671980 60653146 60671982 60561143 60653108 60653109 60653119 60653123 60653124 60653125 60653130 60653134 60653135 60653136 60653139 60653143 60653104 60653118 60653127 60682963 60671976 60653117 60653129 60653132 60661882 60671959 60671977 60671962 60671967 60653142 60621355 60653141 60671965 60671963 60671964 60523364 60612818 60653131 60671961 60615110 60653133 60653140 60536820 60671970 60671978 60671969 60671971 60671972 60671975 60671981 60690731 60653122 60671960 60680440 60653145 60653147 60671973 60671983 60680441 60690733 60702010 60705050 60671966 60671974 60702013 60702012 60702014 60702017 60621352 60671968 60702015 60523382 60690730 60690732 60702019 60702021 60702029 60702037 60705049 60702011 60702016 60702023 60690734 60702018 60702025 60539410 60714821 60714822 60714827 60702031 60727241 60671984 60442552 60714814 60714815 60539411 60714813 60714816 60714817 60714818 60714819 60714825 60733781 60539412 60714820 60736759 60736761 60714826 60721965 60736760 60539407 60714823 60747379 60736763 60736768 60736765 60736769 60736764 60736767 60782054 60782058 60781220 60782055 60782056 60782057 60736772 60781214 60782065 60781216 60781218 60782060 60782067 60782063 60782069 60782064 60782066 60782059 60794238 60782062 60736766 60781215 60782068 60794237 60736770 60736771 60799737 60736773 60736774 60736775 60736776 60781221 60794263 60736777 60781222 60782061 60799738 60799741 60794244 60799739 60799740 60781219 60812161 60817012 60812151 60812152 60812156 60812149 60794245…
FDA’s list runs to 9,377 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: US Nationwide (including PR and USVI), and countries of: Israel, Argentina, Brazil, France, Mexico, Saudi Arabia, Beirut, China, Korea, San Salvador, Honduras, Canada, Australia, Switzerland, Germany, Arab Emirates, UK, Belgium, Egypt, Spain, France, Italy, Iran, Lebanon, Jordan, Iraq, Canary Islands.
The states and territories these words name
- Puerto Rico
- US Virgin Islands
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 Jun 19, 2013.
- FDA classified it on Aug 26, 2013.
- FDA’s Enforcement Report published it on Sep 4, 2013.
- FDA terminated it on Jun 16, 2015.
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: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
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 9,377 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.