{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1398 } }, "results": [ { "cfres_id": "149732", "product_res_number": "Z-0003-2017", "event_date_initiated": "2016-08-08", "event_date_posted": "2016-10-03", "recall_status": "Terminated", "event_date_terminated": "2017-06-05", "res_event_number": "75235", "product_code": "JWH", "k_numbers": [ "K093293" ], "product_description": "Vanguard 360 Revision Knee System\nKnee prostheses", "code_info": "ITEM\tLOT\tDESCRIPTION 185220\t262690\tBMT 360 TIB AUG 59X5MM 185221\t475560\tBMT 360 TIB AUG 63X5MM 185222\t262720\tBMT 360 TIB AUG 67X5MM 185222\t475570\tBMT 360 TIB AUG 67X5MM 185222\t524160\tBMT 360 TIB AUG 67X5MM 185222\t690770\tBMT 360 TIB AUG 67X5MM 185223\t421690\tBMT 360 TIB AUG 71X5MM 185223\t475580\tBMT 360 TIB AUG 71X5MM 185223\t475590\tBMT 360 TIB AUG 71X5MM 185223\t524170\tBMT 360 TIB AUG 71X5MM 185224\t475600\tBMT 360 TIB AUG 75X5MM 185224\t475610\tBMT 360 TIB AUG 75X5MM 185224\t524180\tBMT 360 TIB AUG 75X5MM 185224\t647840\tBMT 360 TIB AUG 75X5MM 185224\t690790\tBMT 360 TIB AUG 75X5MM 185225\t342740\tBMT 360 TIB AUG 79X5MM 185225\t421700\tBMT 360 TIB AUG 79X5MM 185225\t524190\tBMT 360 TIB AUG 79X5MM 185225\t524200\tBMT 360 TIB AUG 79X5MM 185225\t690800\tBMT 360 TIB AUG 79X5MM 185226\t647850\tBMT 360 TIB AUG 83X5MM 185226\t751570\tBMT 360 TIB AUG 83X5MM 185228\t647910\tBMT 360 TIB AUG 91X5MM 185228\t751420\tBMT 360 TIB AUG 91X5MM 185230\t524210\tBMT 360 TIB AUG 59X10MM 185231\t421730\tBMT 360 TIB AUG 63X10MM 185231\t475620\tBMT 360 TIB AUG 63X10MM 185231\t524220\tBMT 360 TIB AUG 63X10MM 185232\t377450\tBMT 360 TIB AUG 67X10MM 185232\t377460\tBMT 360 TIB AUG 67X10MM 185232\t421750\tBMT 360 TIB AUG 67X10MM 185232\t475630\tBMT 360 TIB AUG 67X10MM 185232\t524230\tBMT 360 TIB AUG 67X10MM 185233\t342750\tBMT 360 TIB AUG 71X10MM 185233\t377470\tBMT 360 TIB AUG 71X10MM 185233\t475640\tBMT 360 TIB AUG 71X10MM 185233\t524240\tBMT 360 TIB AUG 71X10MM 185234\t262780\tBMT 360 TIB AUG 75X10MM 185234\t262790\tBMT 360 TIB AUG 75X10MM 185234\t524250\tBMT 360 TIB AUG 75X10MM 185235\t421770\tBMT 360 TIB AUG 79X10MM 185235\t421780\tBMT 360 TIB AUG 79X10MM 185237\t229750\tBMT 360 TIB AUG 87X10MM 185238\t229760\tBMT 360 TIB AUG 91X10MM 185238\t262820\tBMT 360 TIB AUG 91X10MM 185239\t511390\tBMT 360 TIB AUG BOLT 10MM 185241\t148190\tBMT 360 TIB AUG 63X15MM RL/LM 185242\t969710\tBMT 360 TIB AUG 67X15MM RL/LM 185243\t377480\tBMT 360 TIB AUG 71X15MM RL/LM 185247\t262750\tBMT 360 TIB AUG 87X15 RL/LM 185250\t421790\tBMT 360 TIB AUG 59X15MM LL/RM 185251\t262770\tBMT 360 TIB AUG 63X15MM LL/RM 185253\t421800\tBMT 360 TIB AUG 71X15MM LL/RM 185254\t229770\tBMT 360 TIB AUG 75X15MM LL/RM 185255\t229780\tBMT 360 TIB AUG 79X15MM LL/RM 185256\t988680\tBMT 360 TIB AUG 83X15MM LL/RM 185257\t148210\tBMT 360 TIB AUG 87X15 LL/RM 185229-00\t493640\tBMT TIB AUG BOLT 5MM 185229-00\t582090\tBMT TIB AUG BOLT 5MM 185229-00\t582100\tBMT TIB AUG BOLT 5MM 185229-00\t582110\tBMT TIB AUG BOLT 5MM 185229-00\t590570\tBMT TIB AUG BOLT 5MM 185229-00\t789260\tBMT TIB AUG BOLT 5MM 185239-00\t493690\tBMT 360 TIB AUG BOLT 10MM 185239-00\t590580\tBMT 360 TIB AUG BOLT 10MM 185239-00\t590590\tBMT 360 TIB AUG BOLT 10MM 185239-00\t590600\tBMT 360 TIB AUG BOLT 10MM 185239-00\t590610\tBMT 360 TIB AUG BOLT 10MM 185239-00\t590620\tBMT 360 TIB AUG BOLT 10MM 185239-00\t590630\tBMT 360 TIB AUG BOLT 10MM 185239-00\t666760\tBMT 360 TIB AUG BOLT 10MM 185239-00\t666780\tBMT 360 TIB AUG BOLT 10MM", "firm_fei_number": "1825034", "recalling_firm": "Zimmer Biomet, Inc.", "address_1": "56 E Bell Dr", "city": "Warsaw", "state": "IN", "postal_code": "46582-6989", "additional_info_contact": "Customer Service\n800-348-2759", "reason_for_recall": "The drill bit used to drill the hex pre-drilled hole in the screw head of the Tibial Augment Bolts included in the Vanguard 360 Revision Knee System was larger than allowable per the process specification. As a result, the hex geometry can still be visible, but there are radial cuts into the hex flat. Therefore, when the bolt is inserted into the augment, the screwdriver is unable to catch on the hex geometry, or the screwdriver strips the remaining hex geometry, and the bolt is unable to be fully tightened.\n\nThe bolt stripping or the bolt not being fully tightened will be noticed by the surgeon intraoperatively when he or she is unable to screw the augment bolts into the augment. This possible event can result in an intraoperative delay resulting in increased time under anesthesia.", "root_cause_description": "Process control", "action": "Zimmer Biomet sent an URGENT MEDICAL DEVICE RECALL REMOVAL notifications dated August 8, 2016, to all affected customers via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. \n\nIf after reviewing this notice you have further questions or concerns please call 1-800-348-9500 ext. 1251 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of business hours will receive a prompt to record a voicemail and will be returned upon receipt. Alternatively, your questions may be sent by email to CPWARFieldAction@zimmerbiomet.com. For further questions, please call (800) 348-2759.", "product_quantity": "454", "distribution_pattern": "Worldwide Distribution - US Distribution to the states of : VA, UT, TX. OR, MN, AL, PA, CA and KY., and to the countries of : AUSTRALIA, China, Italy, Netherlands and Japan.", "openfda": { "k_number": [ "K160342", "K874923", "K081127", "K093360", "K101281", "K050539", "K140452", "K191192", "K162222", "K853661", "K872379", "K261563", "K952830", "K925072", "K973672", "K102367", "K993692", "K142388", "K961379", "K202684", "K042343", "K904205", "K113378", "K041046", "K922048", "K894334", "K031183", "K220705", "K972864", "K063406", "K111785", "K123339", "K922285", "K122991", "K193057", "K843241", "K081023", "K933867", "K244039", "K911572", "K102125", "K141585", "K202022", "K111492", "K101994", "K102795", "K914169", "K080199", "K162026", "K041085", "K181635", "K071071", "K081458", "K153310", "K212839", "K943462", "K932425", "K032295", "K102580", "K122232", "K980999", "K992167", "K082469", "K871772", "K912147", "K210252", "K946088", "K895962", "K121835", "K010434", "K073286", "K864632", "K100391", "K180446", "K843242", "K143725", "K060569", "K210695", "K082500", 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