Copeland HA Resurfacing Head, MB/HA EAS Head
Medical device recall Z-0527-2020. 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?
Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.
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: 197000 838570 047410 869160 047400 047390 203030 203040 224470 482850 052950 076580 917420 326610 362350 565380 374150 420170 374160 882210 882090 746150 691040 969190 942350 726180…
Every code shown here, 1,997 characters
All lots manufactured between January 2008 - May 2019: 197000 838570 047410 869160 047400 047390 203030 203040 224470 482850 052950 076580 917420 326610 362350 565380 374150 420170 374160 882210 882090 746150 691040 969190 942350 726180 048880 385080 111310 013150 868010 638680 745730 780270 780240 013140 834290 623340 817490 028380 186120 409420 847030 679990 755600 409330 706270 169490 936000 400990 343410 235880 917410 872790 715870 179470 313330 324140 362650 305750 326590 920210 564070 305740 632120 684640 536380 564770 014640R 745910 629320 629350 014640 807570 946770 111280 946800 735450 108390 370610 385070 884110 013160 884080 621660 919220 836010 645380 706600 899340 712500 838730 963630 021010 896300 673910 669190 146510 613110 678830 335900 684340 106100 105780 140000 447810 154700 911280 363670 102500 931980 519820 114830 762310 076570 296510 917390 096130 059170 362810 552990 684260 587040 565220 484880 634740 485340 414520 906620 808780 678310 969290 013240 013250 014670 014850 384890 108310 808790 561410 808770 336710 018410 617860 313520 378380 579070 566190 927200 297800 673900 348320 702090 939400 736230 268220 055290 347210 347230 342820 725450 817310 153990 725430 698880 698890 823840 188130 037810 705530 602470 301330 463540 940980 028450 304010 491810 596490 684830 771630 731090 384570 343400 049790 057690 766800 513670 114820 915280 408980 715850 917370 917380 296500 076560 326600 510940 568130 363140 420030R 420030 808760 099520 917350 414510 629400 808720 014610 813330 044040 484870 621620 694280 694250 739520 991720 563690 671840 983580 250250 190920 231850 390870 757150 799950 517900 204080 764010 114810 249030 915250 061900 917340 076550 917360 131600 320520 348900 326030 565370 788320 610590 200890 462920 540650R 584540 540650 540610 691160 634350 485330 808710 085020 108330 906800 042230 367330 013270 100260 584530 759100 621970 808700 781920 834590 645360 654830 307730 580280 789060 295500 110720 296810 218340 971510 290820 984540…
FDA’s list runs to 43,671 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 43,671 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.