MAKO Integrated Cutting System (MICS) HANDPIECE
Medical device recall Z-0044-2025. Published in FDA’s Enforcement Report on Oct 16, 2024.
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 Oct 16, 2024. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 897 units 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?
Stryker has identified an issue with the characterization process that impacted the constant values assigned to the associated MICS Handpieces.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
897 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
GTIN: 00848486030193; Serial Numbers: 4200075 4200134 4200177 4200179 4200191 4200234 4200235 4200251 4200339 4200351 4200359 4200387 4200427 4200461 4200510 4200515 4200531 4200602 4200608 4200611 4200639 4200641 4200648 4200650 4200653…
Every code shown here, 1,998 characters
GTIN: 00848486030193; Serial Numbers: 4200075 4200134 4200177 4200179 4200191 4200234 4200235 4200251 4200339 4200351 4200359 4200387 4200427 4200461 4200510 4200515 4200531 4200602 4200608 4200611 4200639 4200641 4200648 4200650 4200653 4200671 4200697 4200709 4200712 4200729 4200734 4200757 4200850 4200856 4200868 4200873 4200898 4200902 4200966 4201034 4209747 4209750 4209781 4209789 4209803 4209821 4209864 4209866 4209878 4209882 4209899 4209900 4209950 4209955 4209967 4210004 4210033 4210039 4210051 4210086 4210092 4210098 4210167 4210211 4210213 4210220 4210265 4210267 4210325 4210329 4210359 4210408 4210418 4210439 4210445 4210455 4210503 4210505 4210509 4210522 4219193 4219267 4219400 4219446 4219535 4219682 4219702 4219881 4220005 4220154 4220230 4220237 4220263 4220451 4220452 4220810 4220836 4221090 4221102 4221103 4221106 4221243 4221268 4221335 4221462 4221471 4221563 4221685 4221808 4222927 4222994 4222995 4222996 4222997 4222998 4222999 4223000 4223001 4223003 4223004 4201045 4201114 4201124 4201157 4201200 4201235 4201242 4201254 4201270 4201272 4201303 4201332 4201363 4201371 4201400 4201403 4201410 4201415 4201417 4201469 4201520 4201527 4201551 4201555 4201556 4201557 4201562 4201604 4201620 4201640 4201673 4201678 4201692 4201762 4201771 4201822 4201824 4201830 4201858 4201919 4201933 4210539 4210543 4210558 4210575 4210583 4210587 4210590 4210599 4210603 4210604 4210610 4210620 4210626 4210721 4210746 4210831 4210846 4210850 4210924 4210946 4211026 4211033 4211087 4211102 4211103 4211201 4211205 4211217 4211232 4211233 4211243 4211261 4211268 4211273 4211291 4211315 4211320 4211321 4211391 4211413 4211434 4223005 4223006 4223007 4223008 4223009 4223010 4223011 4223012 4223014 4223015 4223016 4223017 4223018 4223019 4223020 4223021 4223022 4223023 4223024 4223025 4223026 4223027 4223028 4223029 4223030 4223031 4223032 4223033 4223034 4223035 4223036 4223037 4223038 4223039 4223040 4223053 4223054 4223055 4223056 4223057 4223058 4201935 4201941…
FDA’s list runs to 11,413 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 - US Nationwide and the countries of Australia, Germany.
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?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, 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 Aug 7, 2024.
- FDA classified it on Oct 9, 2024.
- FDA’s Enforcement Report published it on Oct 16, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Howmedica Osteonics Corp., of Mahwah, NJ.
- 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 11,413 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.