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FDAFDA · Food and drugs·Recall number Z-0520-2020

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

Published December 4, 2019 · Recall initiated: August 21, 2019

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Zimmer Biomet, Inc.
Distributor
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.
Lot
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
Risk classification
Class II
Area (FDA)
device
Country
United States

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