Class 2 Device Recall n/acustom product

• Date Initiated by Firm: August 21, 2019
• Create Date: November 22, 2019
• Recall Status: Terminated on July 21, 2021
• Recall Number: Z-0526-2020
• Recall Event ID: 83783
• Product Classification: unknown device name - Product Code NA
• Product: Various Custom Products, Item Nos. CP102940; CP102941; CP102942; CP102943; CP102944; CP102945; CP102946; CP102947; CP102948; CP112662; CP112663; CP112664; CP112674; CP112675; CP113771; CP113777; CP113778; CP113782; CP113783; CP114083; CP114090; CP114112; CP114118; CP114148; CP114213; CP114388; CP114436; CP114463; CP114472; CP114478; CP114495; CP114532; CP114561; CP114563; CP114605; CP114695; CP114756; CP114782; CP114783; CP114933; CP114987; CP115008; CP115048; CP115049; CP115050; CP115166; CP115209; CP115212; CP115312; CP115313; CP115314; CP115318; CP115319; CP115320; CP115322; CP115357; CP115358; CP115359; CP115360; CP115362; CP115363; CP115371; CP161304; CP161305; CP161306; CP161307; CP161522; CP161560; CP161735; CP161741; CP161751; CP161752; CP161753; CP161768; CP161793; CP161795; CP161831; CP161867; CP162006; CP162007; CP162008; CP162013; CP162017; CP162042; CP162043; CP162055; CP162084; CP162085; CP162086; CP162121; CP162149; CP162150; PM0000711; PM103016; PM103022; PM103060; PM155537; PM155577; PM155578; PM155580; PM155590; PM155591; PM155592; PM155594; PM155595; PM155602; PM155603; PM155604; PM155610; PM155612; PM155615; PM155616; PM155618; PM155623; PM155630; PM155635; PM155638; PM155640; PM155641; PM155643; PM155644; PM155646; PM155650; PM155653; PM155654; PM155656; PM155660; PM155662; PM155663; PM155677; PM155678; PM155685; PM155686; PM155687; PM155694; PM155698; PM155702; PM155710; PM155711; PM155712; PM155715; PM155717; PM155724; PM155725; PM155727; PM155728; PM155730; PM155734; PM155737; PM155738; PM155742; PM155746; PM155750; PM155751; PM155753; PM155756; PM155757; PM155761; PM155762; PM155767; PM155771; PM155774; PM155780; PM155781; PM155785; PM155789; PM155791; PM155792; PM155793; PM155795; PM155804; PM155806; PM155808; PM155809; PM155812; PM155813; PM155815; PM155818; PM155820; PM155823; PM155825; PM155828; PM155829; PM155840; PM155841; PM155842; PM155843; PM155847; PM155849; PM155850; PM155854; PM155857; PM155860; PM155863; PM155867; PM155868; PM155871; PM155872; PM155879; PM155882; PM155887; PM155888; PM155890; PM155892; PM155893; PM155894; PM155895; PM155897; PM155903; PM155905; PM155909; PM155913; PM155922; PM155926; PM155927; PM155928; PM155929; PM155933; PM155938; PM155939; PM155940; PM155942; PM155945; PM155947; PM155948; PM155950; PM155952; PM155963; PM155965; PM155972; PM155974; PM155979; PM155982; PM155983; PM155986; PM155988; PM155989; PM155991; PM155993; PM155997; PM155998; PM156000; PM156002; PM156007; PM156008; PM156012; PM156035; PM156038; PM156039; PM156041; PM156043; PM156044; PM156047; PM156048; PM156060; PM156061; PM156072; PM156079; PM156085; PM156092; PM156095; PM156101; PM156104; PM156110; PM156116; PM156132; PM156133; PM156143; PM156147; PM156154; PM156165; PM156166; PM156173; PM156184; PM156188; PM156192; PM156193; PM156197; PM156205; PM156207; PM156219; PM156235; PM156236; PM156244; PM156248; PM156254; PM156266; PM156275; PM156280; PM156281; PM156290; PM156292; PM156293; PM156320; PM156329; PM156340; PM156343; PM156345; PM156351; PM156352; PM156356; PM156357; PM156358; PM156362; PM156377; PM156379; PM156382; PM156384; PM156387; PM156388; PM156390; PM156391; PM156392; PM156393; PM156397; PM156402; PM156403; PM156405; PM156406; PM156409; PM156410; PM156431; PM156434; PM156435; PM156438; PM156444; PM156448; PM156453; PM156457; PM156458; PM156460; PM156477; PM156485; PM156489; PM156492; PM156497; PM156501; PM156510; PM156511; PM156520; PM156529; PM156532; PM156533; PM156539; PM156544; PM156546; PM156551; PM156560; PM156561; PM156563; PM156565; PM156567; PM156570; PM156572; PM156573; PM156578; PM156584; PM156589; PM156595; PM156596; PM156604; PM156605; PM156609; PM156610; PM156620; PM156632; PM156641; PM156643; PM156656; PM156663; PM156666; PM156668; PM156674; PM156675; PM156676; PM156680; PM156681; PM156682; PM156684; PM156688; PM156691; PM156692; PM156693; PM156698; PM156700; PM156704; PM156705; PM156713; PM156718; PM156803; PM156814; PM156821; PM156829; PM156830; PM156831; PM156834; PM15
• Code Information: All lots manufactured from January 2008 - May 2019 458330 805800 098150 098170 551700 582720 484570 885530 027260 549910 549930 549920 860410 057750 285620 535000 218160 132060 324940 047780 004120 004130 842140 193730 193600 842160 256170 256190 842150 382410 087590 584580 805780 904960 098160 098180 941910 241310 298790 300880 300890 408260 783420 848300 899690 528130 419980 448560 465460 465440 582640 669460 589030 817000 179900 788490 092880 453280 827050 827070 149670 090400 507780 522500 119230 197000 838570 103090 694060 047390 047400 047410 588340 683450 683480 037200 003870 869160 009630 209340 130810 399780 442740 425020 494290 494300 053330 785350 302010 545270 780360 780400 977760 970270 829750 222760 430770 671900 928740 860460 057730 203030 203040 427270 520000 829600 063830 064580 006930 991750 487720 227890 224470 626900 464300 964110 983020 184550 239200 783270 783290 403570 364850 054110 054160 960050 009820 438200 401880 408150 781210 763830 763790 544580 369920 537340 811220 811320 963080 958520 126020 197000 195230 489320 489590 489830 490700 490840 503260 503710 398840 677530 099100 501430 544030 725100 997570 997560 975970 418720 481160 280200 122050 276260 278030 595380 601710 601700 601730 595820 600810 636330 648400 600600 816490 482850 281380 577580 684070 051290 015910 233430 233270 359560 566560 445750 172350 030870 247430 597870 332340 331070 490540 920450 224420 251940 191060 547260 444650 080060 251170 390910 425180 341320 993180 390900 806420 110870 341340 121770 597460 977930 525350 868480 607660 464650 474060 443870 443160 826490 186970 589550 567500 568630 570100 487210 570690 506800 589820 721950 864570 726280 022340 600430 276040 890550 950370 186030 419000 187110 589260 236170 664770 159400 887090 167020 193000 071070 936700 605110 301000 468560 539170 013780 943830 584750 156710 697680 159500 986190 196320 332830 766240 207810 125050 235260 919740 757020 789410 528640 868980 645490 114740 130640 385520 216810 435600 486190 628720 370630 881420 256320 680170 057750 057730 680700 557830 423080 737810 056070 451490 532920 811110 581310 830450 584440 584430 162100 656120 332880 845140 421470 907980 737020 577210 865520 466780 275720 264380 541890 042360 150630 920760 545720 412190 694920 311430 402680 517200 550180 039790 063370 195230 997570 197000 823130 919710 105930 766960 622310 162390 598200 929000 612360 767390 806980 810230 554930 690100 287710 275620 420300 530260 660360 117440 292130 185920 292140 007740 712160 072110 784330 217050 809270 934930 837160 176270 529630 209030 020940 443320 468180 562130 463650 112000 544860 135220 612300 529580 401010 207310 382210 295690 615910 801240 384350 944240 328460 517460 939390 539600 733990 589930 932260 368050 711170 555310 339730 322770 403790 438780 376430 233310 889980 875070 414760 050470 568660 487550 001770 687820 165760 454530 110500 418750 334620 968360 131800 354670 278110 850570 618540 924720 695890 339610 938860 425020 137250 618690 925090 578700 321680 644290 408070 389150 891160 956430 603020 938090 978470 525860 909040 518060 276590 394320 291120 387410 966710 774530 074050 011200 556010 439900 093010 396670 131760 650240 747740 244810 666770 582360 033660 730550 137120 170300 822110 506410 177790 537650 042730 734550 991780 991760 576770 304580 645390 241310 457660 941750 532110 720320 109760 373390 879710 902470 919320 458790 930850 943880 255810 211580 537220 538610 281870 191850 798890 275460 274450 533350 272760 606240 401780 437560 152770 047250 088530 889870 822120 829750 430770 108430 122290 798870 798890 833440 558550 805800 382410 721040 420210 081280 937130 928170 439040 062360 205290 841780 955590 211790 717680 605400 123190 682900 897960 421560 650230 829600 130450 191230 181590 591130 700740 939060 822250 490720 659250 244660 150390 040310 134510 315890 374770 130760 287200 736180 825570 147110 266970 267000 512540 262940 363110 677760 996770 897650 116430 760430 762840 779480 196960 011170 378840 834140 246700 651520 559910 015290 920050 869970 479220 205310 442740 336130 507780 494300 494290 705110 173380 760180 077170 202310 750010 305500 944080 506680 235010 601270 653390 653380 070290 843970 873140 072740 242860 533360 676870 138470 622070 930110 961370 651380 484190 373430 443740 157100 703760 073790 605100 588610 836330 729530 667240 160530 719500 525900 653720 727120 316550 517650 421570 036600 286550 872930 286080 198320 738980 742200 811230 194530 586790 909350 884490 129270 722950 589610 670560 167600 950390 846930 273610 883440 946230 919080 017120 370170 049800 328010 216230 281420 571610 569280 526920 151740 370280 241640 786520 108390 638920 557020 952620 389180 902980 732250 635780 161640 375690 799700 525940 745480 386200 283280 285620 535000 582720 484570 027260 218160 458330 549930 549920 549910 132060 324940 930740 620300 668770 455300 332010 887060 734450 937270 114500 734480 170910 348950 834050 780870 675490 613890 699400 149940 156070 579190 122100 574740 006930 683480 626900 683450 464300 300890 300880 298790 037200 869290 878000 238180 246960 397420 788490 328050 003870 004130 584580 780400 780360 130810 399780 004120 877420 033770 007160 385020 408830 977760 159760 799840 687150 008820 260200 258920 159790 621700 269670 810210 634170 508820 940830 225720 397430 237190 179540 544250 753730 501080 527490 095490 333780 984840 404080 312780 179770 662570 522510 664400 142950 275880 260090 816030 374430 115360 109830 888690 178630 094650 129830 952590 771690 326450 098640 615650 414870 400370 986350 077180 728730 920800 921860 342330 429750 723620 506520 561110 929100 589950 741930 209350 209370 573460 099590 699240 618930 305470 639710 232930 831590 925250 946730 116440 597290 749240 569430 297250 748550 214490 673820 084110 699300 092170 921610 764020 595260 947750 990450 041270 417450 323120 795930 419480 921900 243500 316210 605120 973010 605180 270400 518370 733980 692970 125290 529300 123540 064550 376930 433010 932610 059590 130200 536290 590880 025100 571090 161760 435060 665920 926030 161870 473900 699860 070460 091600 845150 048170 806980 171930 084780 084800 968810 836780 058140 138580 708210 300230 023100 508060 518910 837960 095540 271590 005400 052840 925710 544110 932730 613030 505180 728920 475630 496780 781170 038760 997350 889540 725110 598210 527270 014860 126460 771190 206450 892830 499480 137800 883970 458730 528540 147100 402940 730730 505410 342380 069230 936450 907970 145390 848700 242850 078580 035560 035570 515780 515790 534580 515800 534570 730180 469150 969830 379800 454850 511120 523700 791960 115210 596200 995500 070640 345170 139040 321200 287360 345090 554820 300060 554550 656090 685380 035580 304560 461000 296390 509780 738050 714100 274320 205290 642420 065520 735890 071920 785130 501660 786380 379810 539650 873100 326980 417080 646120 620310 756540 232000 383150 364500 384310 506770 383160 567570 922270 138950 138960 190150 997290 120380 396530 291070 978020 176050 805760 383420 901190 042880 799710 808050 808050R 846060 187070 298310 805550 389120 260930R 216030 260930 498380 788910 277780 745290 782130 287350 760580 061970 274260 376160 797700 614300 910060 335240 194280 136900 173900 756220 254490 765720 131720 264670 656110 685410 087600 703570 290550 746550 461060 962150 740870 183180 668610 858920 573800 303910 110730 596500 011030 778370 194290 811300 955550 107080 816970 812050 827130 283180 781370 969510 264650 344010 514630 782110 782120 816010 909460 087590 339680 969350 340260 580250 899330 629280 827400 880470 368150 708980 803600 928780 805590 326740 863540 217940 983130R 422880 983130 437720 574730 809110 066880 768350 006110 787090 236430 417110 967140 969640 620350 364540 619080 179390 273120 131170 620320 684910 684920 706410 670240 312210 312250 291290 291340 781360 536360 264630 344000 450630 514620 450620 685390 685400 692890 692880 017780 098380 133900 098720 703550 907670 760570 150610 605520 296210 174440 689930 079790 208520 233310 835760 772950 618500 137940 341380 450880 714460 036720 020760 113540 205400 715520 260250 064750 637300 515060 406910 406920 614280 005400 418390 207430 733400 571350 571360 289970 858940 813760 156320 911240 101230 529780 809100 053120 918880 570950 406190 798630 136890 587290 811290 417100 050510 488670 967160 894410 811470 017390 620340 995510 800260 345210 724930 232270 389590 816960 922310 139050 139060 827100 704410 287370 855870 257830 468720 366760 221040 291250 440150 554940 085280 459190 211940 264620 343990 450610 529680 710030 710020 871090 871100 999540 339650 339640 441850 041420 336690 377590 703540 907660 990490 990500 320200 828380 759040 759010 660000 962130 509790 553080 618570 822890 740860 017890 085800 204390 355380 368140 632660 657280 714230 570820 928900 888200 641150 164590 435850 759420 818680 699240 642440 374780 655070 794210 168360 255490 064740 198650 370060 776090 614260 913400 413580 117570 437710 273810 066890 427250 475130 186750 595630 459600 674420 744730 037170 454620 175780 742470 570940 790240 494000 007650 741150 459660 136880 562600 053830 115220 488800 256560 863240 863240R 488660 685170 132680 488650 764820 764830 017380 006850 691220 506090 364530 567580 611310 345200 765710 816950 138930 138940 228850 527310 827120 724610 057740 483300 706400 243220 885080 885070 028590 291170 291240 554920 554930 542760 313320 678710 974090 974100 310470 384380 450600 971960 554560 637030 637040 656100 710010 994560 335180 139270 472700 703520 469140 732730 934310 990480 990470 344890 374000 721330 721320 399080 399100 242170 399090 525500 962120 640690 801520 790170 738300 085910 054680 179560 236540 506160 367650 945250 709030 709040 641090 925260 957460 910650 435830 901560 385170 642430 048390 065540 867030 065380 415780 867040 427260 427280 971470 406900 657610 991860 746450 761460 657900 657890 983120 417460 565990 504530 354220 784890 236420R 784910 110720 274030 006100 292140 784950 236420 450780 784880 491580 034030 725930 503470 201100 139670 389010 139550 798620 384390 943170 136870 873200 526710 136860 895710 408470 133760 132670 405560 646130 764810 026950 002860 017370 588600 620330 969730 296400 454540 364520 510220 383180 705750 551420 611300 940380 585990 032320 800220 099250 439010 922300 139000 119880 139020 139030 139010 131160 306930 228830 228840 546440 753900 963240 483290 981360 168700 150800 631840 291150 291110 554900 554890 929630 974070 974080 514610 842830 971940 971950 113240 287340 483190 304570 989380 098710 469180 607540 703510 021550 854330 990460 397660 721310 731740 027770 219420 525490 730630 829350 652210 232230 553070 629290 120020 570800 765640 367920 532900 709020 570560 972120 059880 142780 673680 617210 867010 805610 001030 705990 515050 339030 450080 789700 746440 099000 746430 610420 117540 566000 327230 417440 469440 784870 388190 273800 236410 627910 340640 596960 873190 079500 417090 619740 078350 847120 333600 758390 405550 846960 020390 784900 002850 279750 435310 811520 962770 444690 602190 620320 955540 955530 045920 766610 364510 628930 800250 345190 765700 055580 026050 232120 816940 922290 138910 138900 138920 753710 753730 225790 225780 670220 969230 258520 187010 113150 243200 028560 028550 440130 554870 667070 291100 554880 781290 504450 459210 315010 974050 974060 343960 343970 514600 745400 745230 761230 709980 709990 799700 999530 113230 551910 760560 955210 131960 532100 553230 769860 174430 659990 927190 860930 553060 484830 738290 835610 179340 981380 444410 368090 714310 641040 164580 448170 867000 065510 376140 910040 486060 614240 913390 733390 577800 878090 688070 469400 091650 469330 460470 225000 473070 345750 176160 429790 661430 778360 790120 570930 136850 873110 488790 654730 060660 404940 488640 178480 178510 811460 894400 596210 171360 506080 829310 383170 296390 454530 628920 345180 656590 724860 026040 922280 138990 138980 138970 753890 357370 225770 670210 116830 300060 052220 631830 269770 028540 440080 291090 554850 781210 781270 085270 459250 314980 209340 123110 976060 186690 863930 937040 505080 902760 158540 893790 891800 354210 580730 833190 245070 987770 101010 023240 752240 061630 464490 925810 931330 912610 143330 767860 040610 665130 457180 108410 010560 845100 385010 778320 778330 589440 242260 081730 077160 152510 333180 232750 018170 729400 922610 164870 012210 287220 113270 299760 494530 615350 663460 795130 866540 445600 987060 703660 570990 725610 865800 410790 323190 321240 062750 323220 392890 195790 678570 589430 549110 327840 527260 737150 811900 781450 185340 143070 102630 062800 927720 161540 469610 615310 106190 171940 877990 295510 261430 866620 020430 932330 345970 548320 041300 783830 830690 916100 014170 676460 526330 404790 560130 586830 252070 420330 072480 811880 359350 690080 061710 685590 745970 864430 266940 186880 458400 632470 150490 021720 953500 389510 709360 621270 589940 178950 436950 314680 801690 857460 782820 098160 098180 669460 077370 673650 131750 076460 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• Recalling Firm/ Manufacturer: Zimmer Biomet, Inc.; 56 E Bell Dr; Warsaw IN 46582-6989
• For Additional Information Contact: 411 Technical Services; 574-371-3071
• Manufacturer Reason for Recall: Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
• FDA Determined Cause: Environmental control
• Action: On September 11, 2019, the firm began notifying distributors and customers of the recall via an Urgent Medical Device Recall letter. The letter informed consignees of the product issue. Customers were asked to assist their Zimmer Biomet sales representative and quarantine all identified product. The sales representative will remove the product from your facility. If any products were further distributed, please forward the notification to responsible parties. If you have further questions or concerns, please call customer service at 574-371-3071 between 8:00 am and 5:00 pm ET, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com. There are no specific patient monitoring instructions related to this recall that are recommended beyond your existing follow-up schedule.
• Quantity in Commerce: 219988 units (total)
• 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.

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.