VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and short low profiles, several…
Medical device recall Z-2093-2013. 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 II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and short low profiles, several holes/length combinations (2/54, 3/70, 4/86, 5/102, 6/118) and several angles (130, 135, 140, 145 and 150). Item codes starting with 00-1193-130, 00-1193-135, 00-1193-140, 00-1193-145, 00-1193-150. 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
60611022 60611024 60619085 60598271 60598275 60628437 60582010 60625420 60629729 60630044 60630089 60632485 60628439 60630043 60630090 60630091 60630093 60630095 60630098 60632496 60632513 60629728 60630092 60630094 60630096 60632497…
Every code shown here, 1,998 characters
60611022 60611024 60619085 60598271 60598275 60628437 60582010 60625420 60629729 60630044 60630089 60632485 60628439 60630043 60630090 60630091 60630093 60630095 60630098 60632496 60632513 60629728 60630092 60630094 60630096 60632497 60632504 60632506 60646243 60632516 60632527 60646247 60632505 60632514 60646241 60646245 60646256 60648988 60648990 60630045 60646250 60646257 60646260 60646261 60630097 60646251 60664579 60666551 60666553 60630101 60664586 60664589 60664591 60666539 60666552 60666554 60664584 60666570 60646255 60664594 60666550 60666568 60666555 60666557 60666567 60666540 60666544 60666546 60666547 60666548 60664611 60666569 60664616 60666542 60666543 60666556 60666560 60679361 60679362 60679363 60666545 60678765 60678768 60678771 60679351 60679353 60679364 60679345 60679348 60679359 60685057 60666558 60666561 60679349 60679354 60679357 60685086 60685089 60679352 60679360 60666541 60674432 60685033 60685035 60685036 60685038 60685060 60685081 60679355 60685083 60685031 60685072 60699482 60685030 60699487 60699488 60704350 60704351 60704355 60704352 60699489 60704353 60704346 60704354 60704345 60704347 60704348 60704357 60704358 60704360 60714919 60704349 60704359 60685034 60704356 60704361 60704363 60714925 60714920 60714928 60714922 60714924 60704362 60704364 60704365 60714918 60714923 60714926 60714927 60714932 60714934 60714935 60714936 60714965 60714966 60714967 60714968 60726367 60714933 60726368 60726329 60726365 60674435 60726330 60726332 60726364 60726324 60726327 60726328 60726366 60746152 60726320 60726331 60726369 60746137 60746188 60746189 60746190 60746266 60746268 60726321 60746183 60746280 60754394 60726322 60726323 60726370 60746134 60746269 60746273 60746265 60746193 60746270 60763198 60746271 60699490 60726361 60746151 60763201 60763202 60763203 60763204 60763213 60746281 60763199 60763212 60746186 60746267 60746274 60763210 60746185 60746191 60746272 60763197 60763205 60763206 60699483 60746153 60763211 60746184 60763196 60779869…
FDA’s list runs to 12,185 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 12,185 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
-
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.