Pinnacle Cups
Medical device recall Z-0802-2021. Published in FDA’s Enforcement Report on Jan 13, 2021.
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 Jan 13, 2021. 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
- 14161 lots (10 units/lot) 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?
Certain Pinnacle Cup devices may potentially exhibit an oversized “minor diameter”, which could lead the Apex HE to thread through the shell of the cup without stopping or to protrude internally as a result of “cross-threading”. If cross-threading occurs, physicians will not feel the positive stop of the Apex HE against the cup.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Pinnacle Cups, Part numbers 121701048 121701050 121701052 121701054 121701056 121701058 121701060 121701062 121711048 121711052 121712050 121712052 121712056 121722048 121722050 121722052 121722054 121722056 121722058 121722060 121722062 121731048 121731050 121731052 121731054 121731056 121731058 121731060 121731062 121732048 121732050 121732052 121732054 121732056 121732058 121732060 121732062 121732064 - Product Usage: The PINNACLE CUP devices are part of the Pinnacle Hip Solution for the anatomic reconstruction of the hip joint, which promotes prosthetic joint load and function.
14161 lots (10 units/lot), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Lots 8591362 8591361 8591363 8592831 8594131 8593445 8593245 8592830 8596365 8594132 8594461 8596511 8596371 8596372 8596369 8596495 8596510 8597345 8597338 8597347 8597351 8594149 8597340 8597339 8597465 8592165 8596366 8597466 8592829…
Every code shown here, 1,997 characters
Lots 8591362 8591361 8591363 8592831 8594131 8593445 8593245 8592830 8596365 8594132 8594461 8596511 8596371 8596372 8596369 8596495 8596510 8597345 8597338 8597347 8597351 8594149 8597340 8597339 8597465 8592165 8596366 8597466 8592829 8597892 8598955 8597898 8598954 8597341 8597346 8597463 8598953 8599439 8594152 8598421 8597342 8599734 8594155 8598956 8599793 8599801 8599791 8599800 8599448 8599792 8599447 8598945 8599657 8599655 8599790 8599669 8599656 8599894 8600091 8599895 8592317 8599668 8599902 8599803 8599796 8600146 8600148 8600173 8600147 8599665 8599797 8599667 8599664 8599670 8600170 8599663 8599798 8601003 8599899 8601399 8601004 8600169 8601641 8599666 8600172 8601411 8601005 8601634 8601656 8601633 8601644 8601002 8601635 8602769 8600174 8601409 8602929 8599659 8602837 8602915 8602914 8602844 8602930 8602836 8602835 8602838 8602833 8602818 8602839 8602779 8602843 8602913 8602926 8602925 8601414 8602771 8600175 8599608 8600115 8599810 8602815 8602793 8603685 8603631 8604745 8603681 8604756 8602778 8604784 8603663 8604758 8604759 8604744 8602785 8604754 8605058 8606232 8605620 8605059 8605619 8605621 8605624 8606223 8605615 8605071 8605616 8605069 8605061 8605622 8606231 8605070 8605062 8604761 8606227 8605618 8605617 8606229 8606469 8604753 8605074 8606470 8606959 8606956 8607746 8608272 8607772 8608040 8607755 8605066 8608045 8608071 8608044 8608294 8608041 8605065 8608308 8608293 8608303 8608661 8608648 8608669 8610116 8608606 8610340 8610105 8610330 8610337 8610115 8610106 8610850 8610338 8608580 8608312 8607759 8608581 8605073 8607748 8608313 8608573 8610858 8610870 8610873 8611591 8611592 8612926 8611624 8611659 8613062 8613060 8613068 8613061 8611614 8613368 8613065 8613371 8613385 8613370 8613064 8613067 8613066 8613480 8613367 8613483 8613063 8612955 8610111 8613506 8613457 8611656 8611658 8611655 8615242 8616171 8615241 8615213 8616176 8616175 8614807 8616172 8616154 8616179 8617537 8616183 8616173 8616177 8616178 8617532 8616156 8616157…
FDA’s list runs to 123,834 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 distribution.
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 Dec 15, 2020.
- FDA classified it on Jan 7, 2021.
- FDA’s Enforcement Report published it on Jan 13, 2021.
- FDA terminated it on Nov 14, 2023.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- DePuy Orthopaedics, 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 123,834 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.