Magna-Fx Cannulated Screw Fixation System 7.0 mm
Medical device recall Z-1001-2014. Published in FDA’s Enforcement Report on Feb 26, 2014.
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 Feb 26, 2014. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 7,044,680 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?
Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Magna-Fx Cannulated Screw Fixation System 7.0 mm. Item codes starting with 0011420, 11460 and 11461.
7,044,680 total, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
60678937 60725698 60820102 60868357 61099266 61122455 61286984 60356456 60780951 60962055 61041381 61099267 61115876 61197682 60101457 60165562 60207649 60218165 60678939 60714704 60780952 60868358 60932395 61010681 61013650 61107937…
Every code shown here, 1,998 characters
60678937 60725698 60820102 60868357 61099266 61122455 61286984 60356456 60780951 60962055 61041381 61099267 61115876 61197682 60101457 60165562 60207649 60218165 60678939 60714704 60780952 60868358 60932395 61010681 61013650 61107937 61185828 61261813 60154179 60242174 60392816 60714705 60735829 60820103 60861042 60914270 60962060 61030191 61031913 61099268 61107952 61129838 61286986 62311946 60116999 60137567 60264359 60392817 60686417 60735830 60962064 61107953 61144212 61291484 62326539 60137568 60381037 60452034 60678940 60725699 60861044 60885486 61030192 61064420 61107954 61144213 61291485 61627268 62320020 60099553 60124830 60155276 60210916 60279193 60293173 60406084 60678941 60735831 60772796 60820105 60914273 60932397 60962068 61100754 61107955 61141540 61383124 61542613 60099554 60123327 60151759 60165563 60186810 60218909 60323277 60337989 60392818 60641792 60700524 60776686 60861046 60885488 60914275 60932398 61041383 61064421 61107956 61122465 61383125 61523983 61549785 60097901 60151760 60167122 60231230 60242175 60338000 60374541 60678943 60690724 60700525 60820107 60863688 60962072 60997213 61041385 61099269 61107957 61122466 61162278 61185825 60097903 60151761 60186811 60231231 60338011 60374542 60502481 60735832 60776688 60787138 60997215 61099270 61115884 61180535 61282213 62294111 60154180 60172533 60242176 60309839 60381041 60452035 60502489 60735833 60938330 61062712 61064422 61107958 61122467 61141541 61549786 61699534 60099555 60165564 60201193 60242177 60356457 60502490 60735834 60820109 61041387 61099271 61115885 61180536 60137569 60172535 60218167 60264360 60274085 60538627 60569295 60585920 60749370 60861047 60868423 61099273 61122468 61141542 61180537 61466708 61542615 61721886 60279194 60293174 60545074 60588248 60735835 60755954 60820110 61067734 61107959 61122469 61162279 61185824 61513918 61542616 61699535 61707903 60127526 60167124 60264361 60274087 60452036 60569296 60678944 60749371 60820111 60863690 60868424 60962076 61030196…
FDA’s list runs to 24,371 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-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.
These words name no state.
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 Oct 11, 2013.
- FDA classified it on Feb 20, 2014.
- FDA’s Enforcement Report published it on Feb 26, 2014.
- FDA terminated it on Apr 14, 2017.
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: Letter.
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 24,371 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.