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 Replacemen
Check against the official notice below — it lists the full affected range.
Zimmer Biomet, Inc. is recalling 219,988 units of Copeland HA Resurfacing Head and MB/HA EAS Head devices distributed nationwide in the United States and internationally to 22 other countries. The devices were manufactured between January 2008 and May 2019 across numerous lot codes. The recall was initiated because elevated levels of bacterial endotoxin and residual debris remained on the devices due to a cleaning issue.
The source document does not specify a remedy or instructions for what affected consumers should do.
Written by software from the official notice below. Not reviewed by a lawyer.
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
Reason for recall: Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. Distribution: 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. Quantity: 219988 units (total) Lot/code info: 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 8
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.