Class 2 Device Recall Bimetric, Biogroove, Mallory Head modular stem/stem, PAR5 Shell, Reach Revision stem, Recap, Taperloc

• Date Initiated by Firm: August 21, 2019
• Create Date: November 22, 2019
• Recall Status: Terminated on July 21, 2021
• Recall Number: Z-0523-2020
• Recall Event ID: 83783
• 510(K)Number: K023409 K030055
• Product Classification: Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
• Product: 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.
• Code Information: 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 714470 567380 340790 541070 675840 399990 763450 763460 803170 730160 803180 803190 709440 804200 772070 304490 763470 803210 873810 730170 763480 803200 772080 906470 417990 417970 969620 969330 859770 969340 004230 784750 969640 973600 990000 966450 841980 567390 933830 873790 989350 873800 989360 989370 620960 042250 009020 027920 933420 009010 009030 041410 691120 305520 841970 099140 061940 061950 009980 969630 989340 933380 907310 921790 099130 139260 115500 099160 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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.
• 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 = LPH and Original Applicant = BIOMET, INC.