INTERLOCKING IM SCREW SML, MED and LRG
Medical device recall Z-1009-2014. 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?
INTERLOCKING IM SCREW SML, MED and LRG; M/DN TIBIAL I/M NAIL 6 MM to 15 MM. Some items starting with codes 0022530, 0022531, 002532, 0022533, 0022534
7,044,680 total, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
60179289 60196075 60208629 60272379 60279637 60367538 60438316 60575719 60597680 60620340 60714150 60735642 60864016 60937504 61031036 61040654 61120277 61133164 61186040 61325064 61446262 61551621 60129673 60177185 60187385 60363817…
Every code shown here, 1,998 characters
60179289 60196075 60208629 60272379 60279637 60367538 60438316 60575719 60597680 60620340 60714150 60735642 60864016 60937504 61031036 61040654 61120277 61133164 61186040 61325064 61446262 61551621 60129673 60177185 60187385 60363817 60387525 60569948 60602446 60620341 60630482 60711126 60714151 60735643 60808002 60819266 60864018 60864019 60876889 60876890 60956565 61104687 61112613 61133165 61266235 61422229 61458906 61489975 60690743 60711143 60714152 60728336 60735644 60747675 60757046 60789824 60808003 60817590 60838120 60838121 60876892 60876893 60937495 60937496 61031038 61112614 61112651 61158629 61161384 60466661 60615939 60735645 60817572 60847807 61120278 61221431 61263174 61333468 60152966 60196077 60196079 60750994 60806391 60847809 60979630 61226089 61263175 61408290 61504079 60753364 60806396 60817586 60829585 60876926 60931129 61331079 60120568 60140390 60150071 60152967 60165627 60177186 60185172 60190843 60195440 60195442 60243126 60253766 60279638 60279639 60279640 60338431 60349085 60387526 60393389 60422609 60438317 60444815 60472686 60528779 60569949 60602447 60602448 60620342 60653343 60690744 60714153 60735646 60735647 60735648 60811023 60819429 60819430 60864026 60864029 60876928 60937499 60937501 60979623 60985453 61079807 61079808 61086366 61100812 61104688 61140198 61143244 61150035 61161407 61173560 61194688 61231196 61244342 61280079 61293775 61303278 61319424 61383085 61428464 61453389 61516672 61564740 61613173 61657631 61709056 61709069 61763484 60103523 60127531 60130218 60140391 60152968 60172506 60179290 60201128 60201130 60229987 60242009 60265708 60279641 60323303 60323305 60338432 60349086 60387527 60393390 60407650 60438318 60444317 60491698 60569950 60602207 60620343 60653345 60653346 60690745 60714154 60735649 60735650 60808004 60819270 60819273 60864032 60864034 60956555 60956558 60956566 60956567 61064852 61075702 61086367 61100813 61104689 61120279 61143245 61158631 61164107 61173035 61173562 61173564 61173565 61512411…
FDA’s list runs to 74,556 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 74,556 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.