Class 2 Device Recall Compress

• Date Initiated by Firm: August 21, 2019
• Create Date: November 22, 2019
• Recall Status: Terminated on July 21, 2021
• Recall Number: Z-0520-2020
• Recall Event ID: 83783
• 510(K)Number: K172502
• Product Classification: Prosthesis, shoulder, semi-constrained, metal/polymer cemented - Product Code KWS
• Product: COMP RVRS Shoulder Baseplates, including Custom Products, Item numbers 115331S; 115331; 115330S; 115330; 110040610; 110040620; 010000589; CP561861; PM0001456; PM551047; PM551063; PM555137; PM555160; PM555209; PM555322; PM555406; PM555415; ; UDI:; ; (01)00880304475342(17)211128(10)704850; (01)00880304475342(17)220128(10)094500; (01)00880304475342(17)220328(10)856620; (01)00880304475342(17)220528(10)487710; (01)00880304475342(17)220628(10)028860; (01)00880304475342(17)220628(10)028870; (01)00880304475342(17)220628(10)799030; (01)00880304475342(17)220628(10)799070; (01)00880304475342(17)220628(10)929900; (01)00880304532465(17)220628(10)850060; (01)00880304475342(17)220628(10)803010; (01)00880304532465(17)220728(10)026780; (01)00880304475342(17)220828(10)208370; (01)00880304475342(17)220901(10)811210R; (01)00880304475342(17)221028(10)960160; (01)00880304532465(17)221028(10)943820; (01)00880304475342(17)240616(10)237420; (01)00880304475342(17)230909(10)500790; (01)00880304475342(17)221128(10)469390; (01)00880304475342(17)221128(10)864610; (01)00880304532465(17)221128(10)234970; (01)00880304475342(17)221204(10)038140; (01)00880304475342(17)221212(10)630530; (01)00880304475342(17)221212(10)508750; (01)00880304475342(17)221212(10)769380; (01)00880304475342(17)221213(10)801090; (01)00880304475342(17)221213(10)831150; (01)00880304475342(17)221217(10)812790; (01)00880304475342(17)221218(10)543530; (01)00880304475342(17)221219(10)630010; (01)00880304532465(17)221228(10)458650; (01)00880304532465(17)221228(10)752440; (01)00880304532465(17)221228(10)786080; (01)00880304475342(17)230103(10)913540; (01)00880304475342(17)230103(10)628460; (01)00880304475342(17)230103(10)250450; (01)00880304475342(17)230104(10)913530; (01)00880304475342(17)230104(10)994010; (01)00880304475342(17)230107(10)591420; (01)00880304475342(17)230107(10)913550; (01)00880304475342(17)230108(10)732010; (01)00880304475342(17)230111(10)913570; (01)00880304475342(17)230111(10)035570; (01)00880304475342(17)230114(10)918370; (01)00880304475342(17)230117(10)042060; (01)00880304475342(17)230118(10)042100; (01)00880304475342(17)230118(10)014090; (01)00880304475342(17)230121(10)014110; (01)00880304475342(17)230124(10)081050; (01)00880304475342(17)230128(10)967360; (01)00880304532465(17)230128(10)014050; (01)00880304475342(17)230129(10)967280; (01)00880304475342(17)230204(10)913560; (01)00880304475342(17)230205(10)460190; (01)00880304475342(17)230205(10)207400; (01)00880304475342(17)230206(10)081040; (01)00880304532465(17)230207(10)014060; (01)00880304475342(17)230207(10)081030; (01)00880304532465(17)230207(10)843610; (01)00880304532465(17)230207(10)319470; (01)00880304475342(17)230207(10)081060; (01)00880304475342(17)230207(10)274520; (01)00880304475342(17)230208(10)165560; (01)00880304532465(17)230208(10)165530; (01)00880304475342(17)230211(10)165570; (01)00880304532465(17)230211(10)207450; (01)00880304532465(17)230211(10)520910; (01)00880304532465(17)230214(10)112280; (01)00880304475342(17)230214(10)460470; (01)00880304532465(17)230214(10)555280; (01)00880304532465(17)230214(10)173830; (01)00880304532465(17)230215(10)014040; (01)00880304532465(17)230215(10)387150; (01)00880304475342(17)230215(10)165550; (01)00880304475342(17)230215(10)207430; (01)00880304475342(17)230215(10)319510; (01)00880304532465(17)230215(10)512310; (01)00880304532465(17)230215(10)124710; (01)00880304532465(17)230215(10)274460; (01)00880304532465(17)230215(10)322260; (01)00880304532465(17)230215(10)562180; (01)00880304532465(17)230215(10)006420; (01)00880304532465(17)230218(10)319480; (01)00880304475342(17)230218(10)433460; (01)00880304532465(17)230219(10)433400; (01)00880304475342(17)230219(10)319500; (01)00880304532465(17)230219(10)487040; (01)00880304532465(17)230219(10)491250; (01)00880304475342(17)230220(10)446680; (01)00880304532465(17)230220(10)433430; (01)00880304532465(17)230221(10)446660; (01)00880304532465(17)230222(10)433380; (01)00880304475342(17)230222(10)594640; (01)00880304532465(17)230225(1
• Code Information: All lots manufactured between January 2008 - May 2019: 064270 080270 128980 137290 143730 153340 159530 167310 167350 178160 202110 204480 215370 217060 222160 222300 252860 267090 276540 276620 307580 308360 314480 343540 350100 356980 367640 384320 422970 427440 454950 497760 512310 515990 534870 549000 551140 558390 563890 574720 607950 616850 627550 627670 630310 636470 643170 653820 673480 685260 694200 699690 715590 716060 752360 762320 775690 775740 799160 799210 812890 822070 832770 832990 833090 833800 835910 836580 851290 880580 892250 914760 917410 924500 925720 929750 929920 951620 953380 957790 960130 960370 968400 969900 004360 023060 043830 045520 051210 055590 064990 095300 124710 133900 149180 160150 161960 167340 181730 187990 190220 211220 252870 268490 274460 281780 330640 349640 351240 351930 352140 356860 358350 363840 470270 474740 474930 491250 491500 520870 522390 523010 529290 535000 539710 571640 610480 619900 623270 688980 698110 699300 740680 752370 752440 777920 786080 789370 792540 799710 823190 870400 892330 895480 917430 924470 927880 929680 952270 956910 960110 011300 012720 019650 051200 052410 058980 066080 123760 134630 143340 167520 173700 185670 191120 207860 260270 268110 324460 347380 357400 376030 406600 423030 454990 477630 485320 496850 497960 529740 548340 587230 593200 636020 636500 643150 655850 686280 703180 723850 743140 775680 792530 825560 827640 830750 895670 907690 953070 071930 076970 081800 102960 167760 216010 268400 322260 351880 356850 357070 416780 474720 480850 519470 522360 558810 568890 618000 629320 650880 674130 688180 694130 697660 723950 769670 787810 845930 850940 851720 852020 908150 929720 956850 968430 010060 092230 114350 129700 200490 206190 218850 263300 290500 369280 422940 480830 488250 558990 562180 567600 580040 643110 692400 701250 762020 812790 830960 839300 849950 853000 856740 943120 967840 039610 098550 100120 148100 176460 229820 302910 347590 367510 529250 562210 569080 584790 617620 629560 658740 670090 674470 723890 751930 753690 799660 800670 840540 848450 849960 895470 929670 993440 004500 005830 006420 017720 029970 071450 072240 119200 125230 197520 206830 279080 378700 408300 416760 441990 470220 546100 546130 549240 568320 576640 658720 746070 781590 804070 818500 872060 914220 993830 997450 026630 035380 048830 087040 109920 134610 176820 178470 186220 186280 218860 339680 431080 434970 555280 561530 563900 592740 596280 611560 688840 688860 698540 703820 716070 740690 751270 753440 801740 849910 865390 891360 895400 895800 914680 952280 998880 026830 175640 179010 333650 409120 427110 431110 463440 487960 517180 520860 520880 611620 615840 762160 777740 866140 876870 890010 896900 917240 924420 026770 234980 366070 366220 367610 367820 410080 457030 520910 522070 549760 564330 629370 673500 683820 692420 738210 809840 812370 849970 901110 919090 923920 014050 026760 082270 109930 114700 135390 173830 228160 234970 295470 311300 333640 366990 409080 510020 546140 549320 593740 617640 662930 684880 692440 721040 746090 845940 887860 895520 943820 962830 020690 098320 235000 409060 458630 496890 540020 543800 554210 554230 634010 654010 688830 688910 738280 801610 818510 895780 975850 013350 024580 026670 048890 055240 074450 094220 112030 117160 123950 128950 149270 168760 174320 178960 181550 209250 216860 231370 262290 266540 272890 296650 301140 314730 347060 347480 349290 351000 383330 383340 383360 383370 383880 388040 398290 406510 408000 423040 426080 426990 428200 452640 455670 459460 459620 460190 463510 478430 478450 493610 499820 501120 502520 508750 525100 543530 565750 584800 596890 611630 630290 631130 645630 669860 674340 681930 684290 691380 700700 705510 706540 731080 734480 742580 752450 755340 758280 788330 833930 907990 909490 909890 924200 924750 930340 930500 949700 952220 962840 963750 994010 995550 095380 823830 584570 011170 022010 035430 040980 071060 072150 079190 082420 082580 082740 087290 100740 131400 136990 140070 167330 174750 181720 186110 204560 204650 219300 239570 243110 255410 268540 273830 295070 314860 317680 360230 382790 388790 401460 404210 405530 423050 429800 437840 460470 465210 472530 487710 499800 499810 512680 512930 514470 521780 534970 559820 570600 590190 631170 698650 701910 701930 748400 769380 801090 803150 846170 857920 874900 905640 906760 915810 924970 953870 954700 964490 974950 983960 99392020940 027080 035330 038150 082400 148800 150470 153820 223910 244850 257330 268550 318180 337550 427000 432670 445070 464260 477630 478440 487780 499840 634900 634940 499910 500790 518770 569160 574890 578360 582510 604920 607860 610090 706720 710850 755630 763590 770980 812790 818140 822440 827080 854770 865790 887710 918370 960300 057740 173070 670740 090090 102330 157180 167160 174270 209140 229410 240020 257340 263850 330530 330720 384010 388740 420610 433210 478420 514240 517760 517790 524620 531420 538740 582150 591390 596880 680560 731270 732010 744920 762230 795950 810580 851380 856550 876730 887700 910550 918830 941420 968000 350780 4100 026580 056240 102350 131770 153520 205880 209830 249870 364690 380610 383530 411980 466440 524320 524580 524600 530450 543580 576850 610170 610200 715380 731450 799290 830810 831150 915100 952190 101890 176800 182230 197230 207400 239520 244030 270190 311470 321590 404220 420730 475210 491150 538140 576670 628470 674380 685990 700890 737990 753480 833840 864610 927240 940230 967360 974930 450760 025540 044070 061800 191040 249930 257360 274520 356970 388030 426960 427010 433060 437970 463490 475230 493860 524340 559090 559730 577170 584580 617780 630010 656430 698390 705550 711870 732090 741580 770770 810330 811010 954650 963670 994170 042060 071000 158810 209850 254620 263800 364710 370400 432690 432700 433160 454100 481430 524170 524180 524370 559080 560200 610150 637230 762190 777340 861940 871980 960080 961450 843000 670720 874810 055720 061870 070970 086430 164300 172600 172610 182200 208380 292660 295490 314440 408020 432710 433220 440110 474820 514450 518600 530310 550040 577260 588140 588200 594820 610160 634430 641240 684520 731550 779270 803010 824650 863570 924100 924450 014310 037970 061660 061700 081040 112040 130280 153780 237420 250450 256440 256950 256970 383830 454060 530440 550000 550020 559100 628510 663820 680510 739490 797600 838980 918820 924350 924410 173110 035570 038040 038180 042090 050500 070990 109780 277060 283310 340220 381500 415750 420560 436710 454050 465180 469460 487100 524390 524570 530460 559170 560150 610100 610140 628610 680730 681240 791210 856590 882070 882140 926740 967280 981250 061680 061770 082300 118730 130260 182220 191100 212300 277070 283240 283300 295450 295480 364610 432680 508630 524130 524330 524530 550030 586050 596790 596820 610070 610080 628420 628520 699640 699650 712670 721170 798590 846180 863580 925920 927090 941380 941480 961430 966830 995690 096720 109880 152490 162200 234910 234930 268580 310540 374490 408550 441920 456760 474800 499070 561400 591450 650610 688880 692390 763700 771950 801540 901050 933470 944050 960180 038250 042070 061620 061710 061860 071610 128170 130310 215150 244020 250830 256940 283260 283280 295500 307360 307410 310220 349160 351660 351670 359660 364680 426940 433100 433120 436750 469080 481610 504500 524140 524430 524590 524610 524660 532550 549960 559150 583270 610260 610270 628460 628530 641230 720980 797620 799020 804180 811180 822430 869180 881340 901140 922740 924330 924390 924430 926910 945040 960090 961420 973650 981210 026800 056170 074580 135370 139150 169250 306700 351980 367000 409130 410070 431140 457490 458620 497010 499250 558950 591490 593720 676560 688850 692380 692450 696830 704110 838490 849890 866620 866730 895450 901060 901070 914250 924120 943080 026570 028880 038030 038100 038170 044490 070960 071580 071650 082290 092770 172620 182190 208330 208360 209810 243990 250430 250470 256960 263760 277050 283180 283220 293100 295470 307390 310200 310250 310270 319980 321550 321560 321600 334330 334350 369540 381490 405160 426910 433150 004270 026780 026820 109890 109900 129110 152680 158010 206750 234920 275830 281770 281790 281810 336700 408010 408750 465450 496950 496980 549300 561360 561380 561390 561500 561520 591460 639240 639310 688890 728820 745940 787630 843590 850040 857590 857610 914200 919070 943830 959410 964900 026810 109910 135350 135360 135380 135400 135410 135420 135430 137390 146000 146020 148140 204640 234940 234950 234960 234990 259760 281800 295460 349580 408590 454200 456900 458640 458650 458660 460070 487050 487070 496940 520850 520890 520900 520920 520930 561410 561510 561540 566470 591470 591480 592890 593760 606320 688810 688870 692360 692370 692410 692430 746130 762310 807600 838460 849900 849930 849940 850000 850030 850050 850060 887620 902300 914210 914230 914240 914260 914270 914280 933440 933480 933490 933500 943100 943110 943140 943840 943850 943860 107230 107270 215430 295450 349560 349610 352130 498980 517170 696930 738200 746050 804400 867230 913230 925270 997880 020740 075040 107290 107310 109940 127930 151280 151320 151380 152400 226850 446650 546090 567680 597960 636040 643250 746040 788180 818440 867220 895420 926900 943960 004290 004510 014060 045540 066690 107260 156810 227010 302900 324360 351960 371600 377760 431100 456710 522090 560850 610690 656120 674040 696920 702780 723880 746120 746150 746160 783300 848550 004470 075050 111120 125290 129160 141120 145970 148120 148130 151540 151670 152330 152630 153040 259790 357270 374140 408370 494690 532210 561880 568310 611510 673870 696980 702730 788270 801530 845960 845970 866680 892200 895680 909610 983920 004760 014040 111140 112280 118120 141110 146030 152260 152540 152620 177590 206600 206800 209980 215440 229940 281190 306770 314070 314080 349460 352150 374120 387150 433420 456880 494730 494740 549260 560860 561890 633990 659260 675320 675350 675360 675450 701390 701840 731020 746110 771980 777100 784940 801660 848610 865190 866760 909590 995210 004300 015240 041400 082030 091530 092290 107280 107490 118070 118090 125260 151240 151350 170830 175710 206760 219830 234640 315570 315780 349510 351900 371570 377790 424980 433380 499320 568370 592920 593750 610680 612650 632280 639200 746060 761990 787900 838520 845980 876340 914620 938650 984280 004340 004400 047030 075060 080260 107510 129070 151310 157980 162150 171570 177790 187540 209650 214980 215000 264390 319480 352120 357330 408380 408440 408500 408690 431020 456820 457040 457290 500280 500390 514990 517220 532190 571390 571410 593730 610970 658660 676550 701340 707420 740080 745910 745990 761970 801480 895810 895820 914740 938620 953690 977310 994370 995510 996430 004600 047010 075090 092240 092330 111130 129050 142260 145960 151860 152550 156780 170790 177490 177640 177730 206610 206620 206640 206680 215480 229330 229400 229870 281200 287300 302940 302970 306650 327640 349500 349550 349570 444750 446620 457010 457020 457220 457470 487080 489140 494720 499290 517450 569060 610950 638130 639370 675400 740850 745970 746000 746020 746030 762030 763610 772000 787860 787920 790550 828520 848530 876310 876360 901040 901090 907920 914630 948580 951230 978190 980510 984160 984240 984260 004330 014070 019090 020640 020750 092300 092310 092350 129120 141040 142240 145950 148170 150800 151270 151510 152420 160950 161060 162180 206650 206690 226910 230120 230190 234670 239540 264430 271360 281220 305630 314090 314240 314260 336620 336630 336640 336650 336660 349400 349420 349520 374170 392800 392840 392970 393010 393020 408660 422300 444710 444740 444990 445010 456730 456780 456790 456830 456930 457200 457210 457500 457530 512210 522110 527180 532120 532230 532240 546110 560840 563290 567670 576840 610930 616830 628870 633970 633980 634000 639220 639410 675430 702770 738230 745950 745960 761980 762060 763690 787600 788100 801600 801760 801770 838450 843620 845910 848540 865120 876300 876350 876380 907890 909540 914730 948640 959400 984290 004310 004390 004410 004590 004610 004650 047020 047110 075080 075100 092320 107250 111160 125180 125310 125370 125420 129180 141010 141060 145990 151340 151370 151710 151870 152560 153600 153610 153620 160920 162170 171550 177660 180720 180750 209620 210000 229380 229420 229930 229950 230040 234650 259800 264440 264460 271630 271850 305560 306640 306710 306760 310560 314110 336600 349410 349430 349540 349620 352030 352060 352200 357460 392850 392860 393040 408420 408430 408480 408710 422260 433400 444730 444970 445000 445020 456720 456810 457480 457520 490850 499050 499080 517420 532100 543840 563250 563320 567610 567630 569070 576670 592900 592930 606290 610720 612610 617310 639140 643080 658620 673850 676520 701800 738170 740810 745770 745930 763600 763670 787980 788030 788320 801490 801500 801570 845950 848520 848580 848600 848630 866710 895430 895750 901120 902320 905550 905570 907880 907930 913200 948590 948620 948630 953610 953670 959390 984120 984140 996380 004420 004480 004490 004630 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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
• 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.
• Total Product Life Cycle: TPLC Device Report

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.

• 510(K) Database: 510(K)s with Product Code = KWS and Original Applicant = Biomet Manufacturing Corp