VerSys¿ Cemented Revision Calcar (CRC) Hip System Femoral Stems VerSys Heritage Hip System Revision Femoral…
Medical device recall Z-0277-2014. Published in FDA’s Enforcement Report on Nov 20, 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 Nov 20, 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
- 12866 units 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?
Based on a review of historic packaging validations, it was determined that a subset of product packaged in one of the clean rooms at a single Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. The number of samples required for packaging testing (seal integrity and seal strength) to provid
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
VerSys¿ Cemented Revision Calcar (CRC) Hip System Femoral Stems VerSys Heritage Hip System Revision Femoral Stems. Indicated for total hip arthroplasty.
12866 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
00369673 00369898 00369984 00369985 00369988 00369989 00369995 00369996 00369997 00369998 00370074 00370082 00370103 00370161 00370162 00370163 00370165 00370166 00370240 00370241 00370242 00370244 00370245 00370246 00370285 00370299…
Every code shown here, 1,998 characters
00369673 00369898 00369984 00369985 00369988 00369989 00369995 00369996 00369997 00369998 00370074 00370082 00370103 00370161 00370162 00370163 00370165 00370166 00370240 00370241 00370242 00370244 00370245 00370246 00370285 00370299 00370300 00370301 00370371 00370374 00370376 00370377 00370378 00370379 00370382 00370405 00370406 00370407 00370409 00370411 00370417 00370428 00370471 00370475 00370620 00370621 00370906 60486158 60495799 60495801 60545572 60545573 60545574 60565682 60565683 60589392 60589393 60589394 60609870 60609871 60644570 60644588 60644589 60644590 60658265 60658266 60661955 60661956 60661957 60661958 60661959 60661960 60661962 60661964 60661965 60661966 60661968 60661971 60661974 60676452 60676454 60676455 60676456 60676457 60676459 60676460 60676462 60676463 60676464 60676467 60712462 60712463 60712464 60712465 60712468 60712469 60726764 60737992 60737996 60745879 60745880 60745885 60745886 60745887 60745893 60745898 60768909 60768910 60768911 60768912 60768913 60768914 60768915 60768916 60768917 60768918 60768919 60768921 60768925 60768926 60768927 60768928 60768929 60768930 60768931 60768932 60768933 60768934 60770498 60770499 60770501 60770502 60770505 60770513 60770514 60770519 60793095 60793096 60793097 60793098 60793099 60793101 60793102 60793103 60793104 60793105 60793106 60793107 60793161 60793162 60821283 60821284 60821285 60821287 60821288 60821289 60821290 60821291 60821292 60821293 60821294 60821295 60821296 60821297 60821298 60821299 60821301 60821302 60821303 60821304 60821305 60821306 60821307 60821308 60829409 60829410 60829412 60829413 60829414 60829415 60829418 60829425 60864596 60864597 60864598 60864599 60864601 60864602 60864603 60864604 60864605 60864606 60864607 60864608 60864609 60864610 60864611 60864612 60864619 60864620 60864621 60864622 60864623 60864624 60864625 60864628 60873796 60873797 60873798 60873799 60873801 60889514 60889515 60889516 60889533 60889534 60889535 60889536 60889537 60889538 60889539 60889540…
FDA’s list runs to 7,721 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 Puerto Rico and Virgin Islands; and countries of: Australia, Algeria, Belgium, Bolivia, Canada, Canary Islands, Chile, Croatia, Finland, France, Germany, Greece, Guatemala, Honduras, India, Israel, Italy, Japan, Jordan, Lima-Peru, Malaysia, Morocco, Nicaragua, Portugal, Saudi Arabia, Seoul Korea, Serbia, Singapore, South Africa, Spain, Switzerland, Turkey, Utd.Arab.Emir., United Kingdom, and Venezuela.
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 Aug 28, 2013.
- FDA classified it on Nov 14, 2013.
- FDA’s Enforcement Report published it on Nov 20, 2013.
- FDA terminated it on Apr 30, 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 7,721 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.