Hearth Record

Free Lock Femoral Hip Fixation System Compression Tube/Plate, different length

Medical device recall Z-2091-2013. Published in FDA’s Enforcement Report on Sep 4, 2013.

FDA’s own record, on accessdata.fda.gov

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.

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.

Source:

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.

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Which ones are recalled?

Free Lock Femoral Hip Fixation System Compression Tube/Plate, different length (59, 75, 91, 107, 123 mm), holes (2, 3, 4, 5, 6) and degree angles (130, 135, 140, 145 and 150). Item codes starting with 00-1181-130, 00-1181-135, 00-1181-140, 00-1181-145, 00-1181-150). ZIMMER Compression Hip Screw , orthopedic implant.

85, 794 units in total, in FDA’s words.

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Codes to check against yours

60611049 60624520 60619105 60619109 60624518 60624519 60625544 60619107 60619879 60611045 60624521 60625511 60625536 60625542 60582204 60619887 60657047 60646266 60657046 60657070 60657071 60657072 60632725 60657051 60657073 60657083…

Every code shown here, 1,998 characters

60611049 60624520 60619105 60619109 60624518 60624519 60625544 60619107 60619879 60611045 60624521 60625511 60625536 60625542 60582204 60619887 60657047 60646266 60657046 60657070 60657071 60657072 60632725 60657051 60657073 60657083 60657075 60657078 60657088 60625545 60646267 60657049 60657052 60657077 60657079 60657087 60657084 60668304 60668305 60582089 60674430 60674431 60685115 60714886 60714872 60714893 60714875 60714897 60714851 60714890 60714892 60714850 60714877 60714896 60714891 60714894 60763218 60763232 60763219 60763220 60763221 60763226 60763230 60763234 60763223 60763227 60763229 60763222 60763224 60763225 60763231 60763233 60714895 60763228 60803587 60803589 60803591 60803592 60803593 60807853 60807854 60803588 60803590 60807855 60803586 60807868 60815019 60820809 60841203 60820796 60807857 60820798 60820801 60807858 60807859 60807861 60807856 60815017 60807865 60820810 60820807 60868474 60868478 60874089 60874093 60874097 60877491 60868477 60885177 60885178 60885180 60885182 60885175 60885179 60885185 60885184 60902841 60905697 60902842 60902843 60911345 60911346 60911348 60911350 60931165 60931166 60911349 60931164 60938423 60944574 60931167 60931168 60944606 60932394 60944525 60938427 60944551 60968742 60959978 60969382 60972805 60972806 60968739 60968744 60988403 60988405 60962160 60988402 60988407 60988408 60988404 60998291 60998292 61020344 61030741 61020343 61030740 61037492 61030742 61037493 61037494 61048120 61048117 61048116 61048119 61048115 61048121 61027553 61048118 61027552 61076085 61076086 61086854 61086857 61079836 61079834 61092273 61092280 61101553 61092247 61092249 61092258 61092281 61092283 61101552 61101554 61103203 61103208 61101551 61103202 61103204 61103206 61103207 61108242 61108243 61108244 61115872 61114143 61118976 61140178 61162614 61162616 61162617 61162615 61169420 61198462 61264756 61269944 61198455 61162618 61179754 61179757 61198458 61198460 61198461 61209574 61198456 61209572 61209573 61198457 61264754 61269949…

FDA’s list runs to 3,113 characters. The first part is shown; the rest is on FDA’s record.

Source:

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.

Source:

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.

Source:

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.
Source:

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.
Source:

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 3,113 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.
Source:

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.

Source:

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.

How to read a record

Four things every record does, shown on an example record made up for this guide.

An example record, made up for this guide

An example nursing home

Made up for this guide: no real place is shown

Not fully inspected in over two years (CMS flag)

11 health citations at the latest inspection cycle

The state average is 14.3.

Source:

CMS, State and US Averages and Health Deficiencies. Released Oct 28, 2026. Updated monthly.

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Every fact names its source.

Who published it, when, and how often it changes sit beside each fact, with a link to the agency’s own file.

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