INTERLOCKING IM SCREW 4.5 and INTERLOCKING IM SCREW LG Some items starting with codes 0022530
Medical device recall Z-1010-2014. 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 4.5 and INTERLOCKING IM SCREW LG Some items starting with codes 0022530
7,044,680 total, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
60625043 60678699 60690742 60728338 60747676 60757045 60813551 60864020 60864021 60915935 60915936 61003973 60806395 60829584 60864023 60867711 60867767 60550320 60569951 60597681 60653347 60690746 60735651 60757047 60757048 60808005…
Every code shown here, 1,998 characters
60625043 60678699 60690742 60728338 60747676 60757045 60813551 60864020 60864021 60915935 60915936 61003973 60806395 60829584 60864023 60867711 60867767 60550320 60569951 60597681 60653347 60690746 60735651 60757047 60757048 60808005 60817585 60829586 60829587 60864037 60864038 60864040 60867771 61161394 61190864 61194691 61215177 61319429 61379510 60518291 60606752 60620346 60711145 60728343 60757050 60806397 60806398 60829592 60829594 60867782 60867785 61071422 61150075 61173568 61319435 61319436 61379514 60748952 60762088 60806399 60876899 60876901 60876902 61248174 61325065 60123303 60130220 60135214 60142918 60150073 60218846 60243102 60279663 60309141 60323311 60338439 60349093 60387528 60393392 60407659 60422612 60422615 60422617 60422618 60505967 60505968 60569960 60597683 60597684 60602462 60620369 60620371 60690750 60690751 60714161 60714162 60735662 60735663 60757051 60757052 60808010 60808011 60814567 60814568 60829596 60829597 60867787 60867788 60867789 60867790 60867792 60956540 60956547 61003994 61004003 61004006 61004010 61035979 61035980 61064854 61066610 61066611 61071425 61071426 61084123 61100815 61158640 61211625 61211626 61221436 61249859 61271267 61286461 61421225 61496669 61509881 61535667 61564743 61664934 61729550 61729552 61746802 61746803 62262065 60123304 60132558 60142920 60152971 60253769 60253770 60280195 60288490 60310563 60310564 60310565 60323343 60338521 60367544 60393393 60393395 60407661 60410614 60438323 60451198 60472688 60487155 60487156 60491717 60491718 60505969 60602464 60602465 60602466 60602467 60620387 60653365 60690752 60690753 60714165 60735665 60735666 60757057 60757058 60757059 60817613 60829604 60867807 60867809 60867811 60867813 60956553 60979622 60985458 60985459 60985460 61024754 61024757 61031015 61031016 61035968 61035972 61041707 61041709 61041713 61064855 61066614 61066615 61067796 61073739 61091734 61096524 61104693 61133860 61133862 61150093 61153543 61199894 61210272 61224276 61269415 61295067 61362462…
FDA’s list runs to 9,224 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 9,224 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.