Class 1 Device Recall SpF PLUSMini (60 A/W) Implantable Spinal Fusion Stimulator

• Date Initiated by Firm: February 19, 2018
• Create Date: November 02, 2018
• Recall Status: Terminated on August 25, 2020
• Recall Number: Z-0287-2019
• Recall Event ID: 81127
• PMA Number: P850035
• Product Classification: Stimulator, invasive bone growth - Product Code LOE
• Product: SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator ; ; SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
• Code Information: Item # 10-1398W - SpF Plus - Mini 60/W; Serial Numbers: 409180, 409203, 409209, 409462, 409468, 409474, 409687, 409755, 409760, 409175, 409181, 409204, 409437, 409463, 409469, 409475, 409688, 409756, 409754, 409176, 409182, 409205, 409438, 409464, 409470, 409476, 409751, 409757, 409686, 409177, 409200, 409206, 409439, 409465, 409471, 409684, 409752, 409758, 409473, 409178, 409201, 409207, 409440, 409466, 409472, 409685, 409753, 409759, 409467, 409179, 409202, 409208, and 409441 Item # 10-1398M - SpFPlus - Mini 60/M; Serial Numbers: 408491, 408743, 408995, 409272, 409544, 409809, 410069, 408490, 408463, 408239, 408492, 408744, 408996, 409273, 409545, 409810, 410070, 408467, 408464, 408240, 408493, 408745, 408997, 409274, 409546, 409811, 410071, 408468, 408465, 408241 408494 408746 408998 409275 409547 409812 410072 408469 408466 408242 408495 408747 408999 409276 409548 409813 410073 408470 408716 408243 408496 408748 409001 409277 409549 409814 410074 408471 408717 408244 408497 408749 409002 409278 409550 409815 410075 408472 408718 408245 408498 408750 409003 409279 409551 409816 410076 408473 408719 408246 408499 408751 409004 409280 409552 409817 410077 408474 408967 408247 408500 408752 409005 409281 409553 409818 410078 408475 408968 408248 408501 408753 409006 409282 409554 409819 410079 408476 408969 408249 408502 408754 409007 409283 409555 409820 410080 408477 408970 408250 408503 408755 409008 409284 409556 409821 410081 408478 409245 408251 408504 408756 409009 409285 409557 409822 410082 408479 409246 408252 408505 408757 409010 409286 409558 409823 410083 408480 409247 408253 408506 408758 409011 409287 409559 409824 410084 408481 409248 408254 408507 408759 409012 409288 409560 409825 410085 408482 409517 408255 408508 408760 409013 409289 409561 409826 410086 408483 409518 408256 408509 408761 409014 409290 409562 409827 410087 408484 409519 408257 408510 408762 409015 409291 409563 409828 410088 408485 409520 408258 408511 408763 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409991 409213 408446 408450 408419 408671 408923 409191 409457 409727 409992 409214 408447 409217 408420 408672 408924 408438 408691 408942 408689 408940 408436 408938 408421 408673 408925 408439 408692 408943 408690 408941 408437 408939 408422 408674 408926 408440 408442 409216 408435 408687 408434 408686 408423 408675 408927 409215 408432 408684 408936 408430 408682 408934 408424 408676 408928 408933 408433 408685 408937 408431 408683 408935 408425 408677 408929 408429 408681 408428 408680 408932 408679 408931 408426 408678 408930 408427 Item # 10-1335W - SpF - XL IIB 2/DW; Serial Numbers: 222960 223185 223331 223455 223610 224090 224204 224295 224536 222717 222961 223186 223332 223456 223611 224091 224205 224296 224537 222718 222962 223187 223333 223457 223612 224092 224206 224508 224538 222719 222963 223188 223334 223458 223614 224093 224207 224510 224539 222720 223150 223190 223377 223459 223615 224094 224208 224511 224540 222721 223151 223191 223378 223460 223616 224095 224210 224512 224541 222722 223152 223201 223379 223461 223617 224096 224212 224513 224542 222723 223153 223202 223380 223462 223618 224097 224213 224514 224543 222724 223154 223203 223381 223463 223619 224098 224214 224515 224544 222725 223155 223301 223382 223464 223620 224099 224215 224516 224545 222807 223156 223302 223383 223465 223621 224100 224283 224517 224546 222808 223157 223303 223384 223491 223622 224101 224284 224518 224547 222809 223158 223304 223385 223492 223623 224102 224285 224519 224568 222810 223159 223305 223386 223493 224081 224103 224286 224520 224569 222811 223160 223306 223387 223494 224082 224104 224287 224528 224570 222812 223166 223307 223388 223495 224083 224105 224288 224529 224571 222813 223167 223308 223389 223604 224084 224106 224289 224530 224572 222819 223168 223309 223390 223605 224085 224107 224290 224531 224573 222954 223169 223310 223451 223606 224086 224108 224291 224532 224574 222955 223182 223311 223452 223607 224087 224109 224292 224533 224575 222956 223183 223312 223453 223608 224088 224110 224293 224534 222958 222957 223184 223313 223454 223609 224089 224203 224294 224535 and Item # 10-1335M - SpF - XL IIB 2/DM Serial Numbers: 222872 223057 223266 223487 223688 223866 224043 224264 224458 222677 222873 223058 223267 223488 223689 223867 224044 224265 224459 222678 222874 223059 223268 223489 223690 223868 224045 224266 224460 222679 222875 223060 223269 223490 223691 223869 224046 224267 224461 222680 222876 223061 223270 223496 223692 223870 224047 224268 224462 222681 222877 223062 223271 223497 223693 223871 224048 224269 224463 222682 222878 223063 223272 223498 223694 223872 224049 224270 224464 222683 222879 223065 223273 223499 223695 223873 224050 224271 224465 222684 222880 223066 223274 223500 223696 223874 224051 224272 224466 222685 222881 223067 223275 223501 223697 223875 224052 224273 224468 222686 222882 223068 223276 223502 223698 223876 224053 224274 224469 222689 222883 223069 223277 223503 223699 223877 224054 224275 224471 222690 222884 223070 223278 223504 223700 223878 224055 224276 224472 222691 222885 223071 223279 223505 223701 223879 224056 224277 224473 222692 222886 223072 223280 223506 223702 223880 224057 224278 224474 222693 222887 223073 223281 223507 223703 223881 224058 224279 224475 222694 222888 223074 223282 223508 223704 223882 224059 224280 224476 222695 222889 223075 223283 223509 223705 223883 224060 224281 224478 222696 222890 223076 223284 223510 223706 223884 224061 224282 224479 222697 222891 223077 223285 223511 223707 223885 224062 224297 224480 222698 222892 223078 223286 223512 223708 223886 224063 224298 224481 222699 222893 223079 223287 223513 223709 223887 224064 224299 224482 222700 222894 223080 223288 223514 223710 223888 224065 224300 224483 222701 222895 223081 223289 223515 223711 223889 224066 224301 224484 222702 222896 223082 223290 223516 223712 223890 224067 224302 224485 222703 222897 223083 223291 223517 223713 223891 224068 224303 224486 222704 222898 223084 223292 223518 223714 223892 224069 224304 224487 222705 222899 223085 223293 223519 223715 223893 224070 224305 224488 222706 222900 223086 223294 223520 223716 223894 224071 224306 224489 222707 222901 223087 223295 223521 223717 223895 224072 224307 224490 222708 222902 223088 223296 223522 223718 223896 224073 224308 224491 222709 222903 223089 223297 223523 223719 223897 224074 224309 224492 222710 222904 223090 223298 223524 223720 223898 224075 224310 224493 222711 222905 223091 223299 223525 223721 223899 224076 224311 224494 222712 222906 223092 223300 223526 223722 223900 224077 224312 224495 222713 222907 223093 223314 223527 223723 223901 224078 224313 224496 222714 222908 223094 223315 223528 223724 223902 224079 224314 224498 222715 222909 223095 223316 223529 223725 223903 224080 224315 224499 222716 222910 223096 223317 223530 223726 223904 224111 224316 224500 222726 222911 223097 223318 223531 223727 223905 224112 224317 224501 222727 222912 223098 223319 223532 223728 223906 224113 224318 224502 222728 222913 223099 223320 223533 223729 223907 224114 224319 224503 222729 222914 223100 223321 223534 223730 223908 224115 224320 224504 222730 222915 223101 223322 223535 223731 223909 224116 224321 224505 222731 222916 223103 223323 223536 223732 223910 224117 224322 224506 222732 222917 223104 223324 223537 223733 223911 224118 224323 224507 222733 222918 223105 223325 223538 223734 223912 224119 224324 224509 222734 222919 223106 223326 223539 223735 223913 224120 224325 224521 222735 222920 223107 223327 223540 223736 223914 224121 224326 224522 222736 222921 223108 223328 223541 223737 223915 224122 224327 224523 222737 222922 223109 223329 223542 223738 223916 224123 224328 224524 222738 222923 223110 223330 223543 223739 223917 224124 224329 224525 222739 222924 223111 223335 223544 223740 223919 224125 224330 224526 222740 222925 223112 223336 223545 223741 223920 224126 224331 224527 222741 222926 223113 223337 223546 223742 223921 224127 224332 224548 222742 222927 223114 223338 223547 223743 223922 224128 224333 224549 222743 222928 223115 223339 223548 223744 223923 224129 224334 224550 222744 222929 223116 223340 223549 223745 223924 224130 224335 224551 222745 222930 223117 223341 223550 223746 223925 224131 224336 224552 222746 222931 223118 223342 223551 223747 223926 224132 224337 224553 222747 222932 223119 223343 223552 223748 223927 224133 224338 224554 222748 222933 223120 223344 223553 223749 223928 224134 224339 224555 222749 222934 223121 223345 223554 223750 223929 224135 224340 224556 222750 222935 223122 223346 223555 223751 223930 224136 224341 224557 222751 222936 223123 223347 223556 223752 223931 224137 224342 224558 222752 222937 223124 223348 223557 223753 223932 224138 224343 224559 222753 222938 223125 223349 223558 223754 223933 224139 224344 224560 222754 222939 223126 223350 223559 223755 223934 224140 224345 224561 222755 222940 223127 223351 223560 223756 223935 224141 224346 224562 222756 222941 223128 223352 223561 223757 223936 224142 224347 224563 222757 222942 223130 223353 223562 223758 223937 224143 224348 224564 222758 222943 223131 223354 223563 223759 223938 224144 224349 224565 222759 222944 223132 223355 223564 223760 223939 224145 224350 224566 222760 222945 223133 223356 223565 223761 223940 224146 224351 224567 222761 222946 223134 223357 223566 223762 223941 224147 224352 224576 222762 222947 223135 223358 223567 223763 223942 224149 224353 224577 222763 222948 223136 223359 223568 223764 223943 224150 224354 224578 222764 222949 223137 223360 223569 223765 223944 224151 224355 224580 222765 222950 223138 223361 223570 223766 223945 224152 224356 224581 222766 222951 223139 223362 223571 223767 223946 224153 224357 224582 222767 222952 223140 223363 223572 223768 223947 224154 224358 224583 222768 222953 223141 223364 223573 223769 223948 224155 224359 224584 222769 222964 223142 223365 223574 223770 223949 224156 224360 224585 222770 222965 223143 223366 223575 223771 223950 224157 224361 224586 222771 222966 223144 223367 223576 223772 223951 224158 224362 224587 222772 222967 223145 223368 223577 223773 223952 224159 224363 224588 222773 222968 223146 223369 223579 223774 223953 224160 224364 224589 222774 222969 223147 223370 223580 223775 223954 224161 224365 224590 222775 222970 223148 223371 223581 223776 223955 224162 224366 224591 222776 222971 223149 223372 223582 223777 223956 224163 224367 224592 222777 222972 223161 223373 223583 223778 223957 224164 224368 224594 222778 222973 223162 223374 223584 223779 223958 224165 224369 224595 222779 222974 223163 223375 223585 223780 223959 224166 224370 224596 222780 222975 223164 223376 223586 223781 223960 224167 224371 224597 222781 222976 223165 223391 223587 223782 223961 224168 224372 224598 222782 222977 223170 223392 223588 223783 223962 224169 224373 224599 222783 222978 223171 223393 223589 223784 223963 224170 224374 224600 222784 222979 223172 223394 223590 223785 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• Recalling Firm/ Manufacturer: Zimmer Biomet, Inc.; 1800 W Center St; Warsaw IN 46580-2304
• For Additional Information Contact: 411 Technical Services; 574-371-3071
• Manufacturer Reason for Recall: Lack of adequate validation and controls to ensure that product cleanliness parameters were consistently met.
• FDA Determined Cause: Under Investigation by firm
• Action: The firm, Zimmer Biomet, sent an "URGENT MEDICAL DEVICE RECALL" letter dated 2/22/2018 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. Complete Attachment 1  Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form must be returned even if you do not have affected products at your facility. 4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. 5. If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, 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.
• Quantity in Commerce: 4,879 units (2,982 units have been implanted and 537 have been scrapped)
• Distribution: US Nationwide Distribution: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV ; and country of: Australia.
• 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.

• PMA Database: PMAs with Product Code = LOE and Original Applicant = EBI, LLC