Hearth Record

Free Lock Femoral Hip Fixation System Compression Lag Screw

Medical device recall Z-2090-2013. 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 Lag Screw . Several lengths (55 to 150 mm) and diameters (12.7 and 15. 8 mm). Item codes starting with 00-1181-05, 00-1181-10 and 00-1181-15. 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

60621340 60621339 60621342 60621345 60639475 60621341 60621338 60621344 60671954 60653031 60653066 60671958 60639474 60653032 60653043 60653053 60653063 60671956 60671957 60705048 60653057 60653069 60671955 60621343 60705047 60714810…

Every code shown here, 1,998 characters

60621340 60621339 60621342 60621345 60639475 60621341 60621338 60621344 60671954 60653031 60653066 60671958 60639474 60653032 60653043 60653053 60653063 60671956 60671957 60705048 60653057 60653069 60671955 60621343 60705047 60714810 60705044 60701995 60705045 60701998 60702002 60705043 60702006 60680439 60736748 60781210 60781213 60781212 60781211 60782044 60782047 60782049 60705046 60714808 60782048 60782043 60782050 60736749 60714809 60736750 60782046 60736752 60736753 60736756 60782040 60782045 60736754 60781209 60782041 60812142 60812145 60782037 60812143 60812147 60815943 60564710 60812146 60817011 60782042 60812141 60812144 60812148 60815946 60830649 60830650 60830670 60830652 60572991 60736755 60736758 60862361 60862362 60862363 60862364 60862365 60862366 60862367 60879681 60862369 60879678 60862368 60564708 60915347 60931209 60931208 60931211 60931212 60931213 60931215 60973693 60973694 61026401 61026409 61026399 61026402 61026406 61026414 61026415 61026405 61026403 61026407 61026404 61045321 61026411 61037587 61037589 61037588 61037586 61037590 61037591 61063230 61069128 61063232 61069129 61069131 61069132 61077253 61083091 61083092 61083093 61077251 61108038 61110037 61110038 61114907 60879682 61120993 61120992 61141516 61141512 61141515 61141517 61142760 61141513 61141514 61142759 61142761 61142762 61171562 61171564 61171565 61184407 61184409 61184410 61141518 61142763 61179647 61184408 61195103 61184405 61184406 61195101 61195104 61195097 61195095 61195096 61195102 61195094 61195099 61195098 61209057 61275454 61251129 61251131 61209056 61209053 61275452 61278174 61278175 61278176 61284325 61284326 61284327 61284328 61286932 61274845 61209054 61209055 61251130 61278171 61284322 61284324 61286935 61286938 61286940 61195093 61278172 61278173 61275456 61268917 61278177 61399023 61310083 61345993 61393376 61400219 61345995 61379219 61405653 61420626 61420628 61420629 61420631 61405652 61466805 61466807 61466808 61466814 61428488 61466840 61428485 61502706…

FDA’s list runs to 2,339 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 2,339 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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