FDAFDA · Food and drugs·Recall number Z-0523-2020
Various Hip systems, Item Nos. 104207 104212 104215 11-162809 11-162810 11-162811 11-162812 11-162813 21-103202 21-103203 21-103204 21-103205 21-103206 21-103207 21-103208 21-103209 21-103210 21-103211 21-103212 21-103215 21-104109 21-104110 21-104111 21-104112 21-104113 21-104114 21-104115 21-104116 21-104117 21-104118 21-104119 21-108110 21-108112 21-108115 21-108117 21-108119 21-108130 21-108132 21-108135 21-108137 21-108139 21-108150 21-108152 21-108155 21-108157 21-108159 21-108251 21-108253 21-108255 21-108257 21-108259 21-108271 21-108273 21-108275 21-108277 21-108279 21-108291 21-108293 21-108295 21-108297 21-108299 21-108391 21-108393 21-108395 21-108397 21-108399 21-109256 21-109260 21-109264 21-109268 21-109272 21-123202 21-123203 21-123204 21-123205 21-123206 21-123207 21-123208 21-123209 21-123210 21-123211 21-123212 21-124309 21-124310 21-124311 21-124312 21-124313 21-124314 21-124315 21-124316 21-124317 US157338 US157340 US157342 US157344 US157346 US157348 US157350 US157352 US157354 US157356 US157358 US157359 US157360 X21-180307 X21-180308 X21-180309 X21-180310 X21-180311 X21-180312 X21-180313 X21-180314 X21-180315 X21-180316 X21-180317 X21-180318 X21-180319 X21-180320 X21-180321 X21-182308 X21-182309 X21-182310 X21-182311 X21-182312 X21-182313 X21-182314 X21-182315 X21-182316 X21-182317 X21-182318 X21-182319 X21-182320 X21-182321 Product Usage: Hip arthroplasty.
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 272750 155610 197670 341720 341750 174760 838240 504840 360250 735990 174770 272100 742290 414230 133510 723450 642570 642520 504830 020840 115890 679780 642620 679870 344370 642510 790050 360240 708170 707970 707980 788870 788880 642490 360270 742270 669070 642580 642600 642610 569050 888950 548290 823580 788860 888990 360260 708180 790060 642540 133500 708160 766460 642550 790070 669060 707960 888980 012620 824370 969280 943520 974890 974950 969500 589060 788850 504810 504850 969490 973990 969450 995270 504820 708190 969310 969290 969300 974940 956050 838230 642500 974020 974900 974910 974920 974930 969430 974010 613610 974000 568870 591100 341710 458340 956060 670530 056780 956450 723460 969470 969460 974030 360280 679800 874570 685800 797060 200790 679790 622410 642560 960010 056820 073810 790100 074730 969370 212250 974960 099550 969400 974970 166470 974040 956070 133490 974880 230500 230520 067820 953720 969320 230490 418630 074720 308850 969480 343870 167200 969350 247310 679860 230510 969380 969410 264610 343860 195100 343910 368670 368680 380570 265470 056810 368650 343880 368660 056790 328870 969420 969360 959990 322750 969340 328460 193940 053890 236450 042260 310460 344700 344710 344720 056800 328880 328890 344740 617850 343890 343900 591050 236220 230470 451080 617830 617860 344680 230480 328860 344730 969260 825660 328780 195110 450590 473130 342020 723440 720460 959980 416500 344690 497210 515120 571200 515070 429200 585850 736360 440880 473110 451110 451130 473120 344750 265490 450580 529670 554540 265480 515080 637650 515100 637660 515110 515130 590260 529660 554530 637020 590250 344770 723430 209290 458310 730320 714270 590240 590230 530160 656950 515060 590220 451100 571150 368900 455980 545990 509860 656070 656080 451090 709940 617930 753280 656060 384800 515090 656940 408210 408220 195180 328800 782090 709970 188790 762200 711280 892200 656960 349850 871200 617910 591040 895180 871220 782410 895190 871210 932270 827790 817060 523500 328790 761210 842780 554520 709920 709930 909450 709950 753290 787220 842820 761220 817080 842790 842810 709960 656970 762180 762170 402730 846050 049910 733510 591030 977710 387280 617870 591760 959970 960000 956460 909760 169330 134540 035790 971910 017760 971930 981440 018610 981430 782100 787210 971900 017770 753300 574430 591090 767070 455990 767090 617880 497500 591020 946740 320690 959960 999520 872780 262420 981410 971920 909770 113200 169320 261470 767060 767110 246670 176030 909750 949930 035780 073390 334900 571190 571160 731070 550160 130550 305150 305160 087910 261480 305180 305140 246680 305190 288220 113210 087580 113220 288150 711290 288230 305210 395000 591010 340880 305290 304430 087570 304520 305200 314010 484190 229420 340810 767080 304470 483130 304510 339610 304530 288210 288200 314020 441810 418000 340900 340910 307920 339590 483140 241730 842720 418010 842710 417930 767100 205390 229430 288280 516860 304540 304550 617890 617920 484210 304450 441820 328190 287330 340820 501760 501780 675820 288240 305240 304420 603910 134550 288170 288180 484200 340860 340870 305230 340890 304480 565630 313760 339600 313770 340830 168210 981420 340840 292030 292050 304460 501750 340850 288290 292020 340930 305280 305300 484220 288260 288300 304440 813340 714480 627180 784530 675810 516850 340920 484230 501740 288160 392260 541060 340800 692370 692380 288190 501790 784540 288250 675830 288270 307930 552760 726820 950900 918490 764050
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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