FDA Device recall Z-0527-2020
Copeland HA Resurfacing Head, MB/HA EAS Head
- FDA Device
- Class II
- terminated
- Published 2019-12-04
On 2019-12-04 the FDA classified a Class II recall of Copeland HA Resurfacing Head, MB/HA EAS Head by Zimmer Biomet, citing elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0527-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-08-21 |
| Published | 2019-12-04 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Zimmer Biomet |
| Distribution | US |
Product
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.
Reason
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
Identifiers
| code_info | All lots manufactured between January 2008 - May 2019: 197000 838570 047410 869160 047400 047390 203030 20304…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 09613 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0527-2020%22
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