DELTA XTEND” Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants are intended for use…
Medical device recall Z-0833-2018. Published in FDA’s Enforcement Report on Mar 7, 2018.
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 Mar 7, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Not named no state, in where it went
- 23,053 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?
The affected lots are being recalled because the epiphysis may not assemble to the stem, which may cause a surgical delay.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
DELTA XTEND” Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants are intended for use in total shoulder or hemi-shoulder replacement procedures in patients with non-functional rotator cuffs. HA components are for cementless use only.
23,053 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
5248487 5248488 5248489 5248490 5248491 5248497 5248498 5248499 5248500 5248501 5250420 5250421 5250422 5250423 5250424 5251136 5251137 5251138 5251139 5251140 5261339 5261340 5261341 5261342 5261343 5262077 5262078 5262079 5262080 5262081…
Every code shown here, 2,000 characters
5248487 5248488 5248489 5248490 5248491 5248497 5248498 5248499 5248500 5248501 5250420 5250421 5250422 5250423 5250424 5251136 5251137 5251138 5251139 5251140 5261339 5261340 5261341 5261342 5261343 5262077 5262078 5262079 5262080 5262081 5263090 5263091 5263203 5263204 5263205 5263206 5263798 5263799 5264519 5264520 5265494 5265495 5265496 5265497 5265498 5265499 5266088 5266089 5266090 5266592 5266593 5268090 5268091 5268092 5268093 5268474 5269235 5269741 5269742 5269743 5269744 5269745 5270942 5270943 5270944 5270945 5271415 5271416 5271417 5273260 5273261 5273262 5273263 5273264 5273265 5274694 5274695 5274696 5275978 5275979 5276798 5276799 5276800 5276801 5276802 5276803 5277832 5277833 5277834 5277835 5277836 5277843 5277844 5277845 5279892 5279893 5280180 5280181 5280182 5281491 5281492 5281493 5281494 5282646 5282647 5282648 5283244 5283245 5283246 5284416 5284417 5284418 5284419 5284420 5284421 5284422 5284991 5284992 5286447 5286448 5286449 5286684 5288257 5288258 5288259 5288478 5288479 5288480 5288481 5289306 5289307 5289308 5289309 5289311 5289599 5289600 5289601 5253183 5253184 5253185 5262086 5262087 5262088 5263207 5263208 5263800 5263801 5263802 5263803 5264934 5264935 5264936 5264937 5264938 5265500 5265501 5266594 5266595 5266596 5266597 5270354 5270355 5270356 5270946 5270947 5271418 5271419 5271420 5271421 5271422 5271423 5273266 5273267 5274697 5274698 5276804 5276805 5276806 5277846 5279354 5279355 5279356 5279894 5279895 5280183 5280184 5281495 5282649 5282650 5282651 5282652 5283247 5283248 5283249 5283250 5284423 5284424 5284425 5284426 5284993 5284994 5286685 5286686 5286687 5289312 5289313 5289314 5289315 5289607 5289608 5248482 5248483 5248484 5248485 5248486 5248492 5248493 5248494 5248495 5248496 5250425 5250426 5250427 5250428 5250429 5251141 5251142 5251143 5251144 5251145 5262082 5262083 5262084 5262085 5263209 5263210 5263211 5263212 5264521 5264939 5264940 5264941 5264942 5264943 5264944 5264945 5264946 5266598 5266599 5266600…
FDA’s list runs to 3,519 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.
Nationally
These words name no state.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
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 Aug 31, 2017.
- FDA classified it on Mar 1, 2018.
- FDA’s Enforcement Report published it on Mar 7, 2018.
- FDA terminated it on Mar 12, 2020.
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 3,519 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.