Various Hip systems
Medical device recall Z-0523-2020. Published in FDA’s Enforcement Report on Dec 4, 2019.
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 Dec 4, 2019. 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
- 219988 units (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?
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Various Hip systems, Item Nos. 104207 104212 104215 11-162809 11-162810 11-162811 11-162812 11-162813 21-103202 21-103203 21-103204 21-103205 21-103206 21-103207 21-103208 21-103209 21-103210 21-103211 21-103212 21-103215 21-104109 21-104110 21-104111 21-104112 21-104113 21-104114 21-104115 21-104116 21-104117 21-104118 21-104119 21-108110 21-108112 21-108115 21-108117 21-108119 21-108130 21-108132 21-108135 21-108137 21-108139 21-108150 21-108152 21-108155 21-108157 21-108159 21-108251 21-108253 21-108255 21-108257 21-108259 21-108271 21-108273 21-108275 21-108277 21-108279 21-108291 21-108293 21-108295 21-108297 21-108299 21-108391 21-108393 21-108395 21-108397 21-108399 21-109256 21-109260 21-109264 21-109268 21-109272 21-123202 21-123203 21-123204 21-123205 21-123206 21-123207 21-123208 21-123209 21-123210 21-123211 21-123212 21-124309 21-124310 21-124311 21-124312 21-124313 21-124314 21-124315 21-124316 21-124317 US157338 US157340 US157342 US157344 US157346 US157348 US157350 US157352 US157354 US157356 US157358 US157359 US157360 X21-180307 X21-180308 X21-180309 X21-180310 X21-180311 X21-180312 X21-180313 X21-180314 X21-180315 X21-180316 X21-180317 X21-180318 X21-180319 X21-180320 X21-180321 X21-182308 X21-182309 X21-182310 X21-182311 X21-182312 X21-182313 X21-182314 X21-182315 X21-182316 X21-182317 X21-182318 X21-182319 X21-182320 X21-182321 Product Usage: Hip arthroplasty.
219988 units (total), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
All lots manufactured between January 2008 - May 2019 272750 155610 197670 341720 341750 174760 838240 504840 360250 735990 174770 272100 742290 414230 133510 723450 642570 642520 504830 020840 115890 679780 642620 679870 344370 642510…
Every code shown here, 2,000 characters
All lots manufactured between January 2008 - May 2019 272750 155610 197670 341720 341750 174760 838240 504840 360250 735990 174770 272100 742290 414230 133510 723450 642570 642520 504830 020840 115890 679780 642620 679870 344370 642510 790050 360240 708170 707970 707980 788870 788880 642490 360270 742270 669070 642580 642600 642610 569050 888950 548290 823580 788860 888990 360260 708180 790060 642540 133500 708160 766460 642550 790070 669060 707960 888980 012620 824370 969280 943520 974890 974950 969500 589060 788850 504810 504850 969490 973990 969450 995270 504820 708190 969310 969290 969300 974940 956050 838230 642500 974020 974900 974910 974920 974930 969430 974010 613610 974000 568870 591100 341710 458340 956060 670530 056780 956450 723460 969470 969460 974030 360280 679800 874570 685800 797060 200790 679790 622410 642560 960010 056820 073810 790100 074730 969370 212250 974960 099550 969400 974970 166470 974040 956070 133490 974880 230500 230520 067820 953720 969320 230490 418630 074720 308850 969480 343870 167200 969350 247310 679860 230510 969380 969410 264610 343860 195100 343910 368670 368680 380570 265470 056810 368650 343880 368660 056790 328870 969420 969360 959990 322750 969340 328460 193940 053890 236450 042260 310460 344700 344710 344720 056800 328880 328890 344740 617850 343890 343900 591050 236220 230470 451080 617830 617860 344680 230480 328860 344730 969260 825660 328780 195110 450590 473130 342020 723440 720460 959980 416500 344690 497210 515120 571200 515070 429200 585850 736360 440880 473110 451110 451130 473120 344750 265490 450580 529670 554540 265480 515080 637650 515100 637660 515110 515130 590260 529660 554530 637020 590250 344770 723430 209290 458310 730320 714270 590240 590230 530160 656950 515060 590220 451100 571150 368900 455980 545990 509860 656070 656080 451090 709940 617930 753280 656060 384800 515090 656940 408210 408220 195180 328800 782090 709970 188790 762200 711280 892200 656960 349850 871200 617910 591040 895180 871220 782410…
FDA’s list runs to 156,160 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.
US Nationwide distribution and countries of Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecuador, El Salvador, Italy, Netherlands, India, Japan, Korea, Malaysia, Mexico, New Zealand, Panama, Singapore, Taiwan, Thailand, Trinidad and Tobago, and Venezuela.
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 Aug 21, 2019.
- FDA classified it on Nov 22, 2019.
- FDA’s Enforcement Report published it on Dec 4, 2019.
- FDA terminated it on Jul 21, 2021.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Zimmer Biomet, 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 156,160 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.