{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-04-08", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "status": "Terminated", "city": "Warsaw", "state": "IN", "country": "United States", "classification": "Class I", "openfda": {}, "product_type": "Devices", "event_id": "81127", "recalling_firm": "Zimmer Biomet, Inc.", "address_1": "1800 W Center St", "address_2": "N/A", "postal_code": "46580-2304", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "Letter", "distribution_pattern": "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.", "recall_number": "Z-0287-2019", "product_description": "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", "product_quantity": "4,879 units (2,982 units have been implanted and 537 have been scrapped)", "reason_for_recall": "Lack of adequate validation and controls to ensure that product cleanliness parameters were consistently met.", "recall_initiation_date": "20180219", "center_classification_date": "20181101", "termination_date": "20200825", "report_date": "20181107", "code_info": "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 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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 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