{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "176440", "product_res_number": "Z-0533-2020", "event_date_initiated": "2019-08-21", "event_date_created": "2019-11-22", "recall_status": "Terminated", "event_date_terminated": "2021-07-21", "res_event_number": "83783", "product_code": "MBF", "k_numbers": [ "K043100" ], "product_description": "BIOMOD PORCOAT HA GLENTRAY; Custom Shoulder Products\n\n\nItem Nos. PM0000097\nPM555140\nPM555147\nPM555319\nPM555418\n113867\n113865\n113863\nProduct Usage: Total Shoulder Replacement", "code_info": "LOTS  584440 823130 966710 653720 191230 361690 917170 993450 009590 971720 197730 421300 970590 799740 713840 265680 924350 729030 843020 729020 034400 279060 958550 451520 040360 364420 399470 417590 446550 449550 489790 572090 587200 609410 616720 965280 975560 996130 873200 287000 951480 031170 659320 830600 297280 407350 907020 751730 641070 713850 729050 729040 960150 957220 451540 299920 564400 150450 770600 364540 146250 761320 957590 868620 537430 810590 364560    UDI  (01)00887868226441(17)270911(10)823130 (01)00880304804180(17)251120(10)966710 (01)00880304860001(17)270228(10)191230 (01)00880304443044(17)230220(10)265680 (01)00880304443044(17)230315(10)729030 (01)00880304443044(17)230319(10)843020 (01)00880304443044(17)230328(10)729020 (01)00880304443044(17)230430(10)034400 (01)00880304443044(17)230520(10)279060 (01)00880304443044(17)230816(10)958550 (01)00880304443044(17)240212(10)451520 (01)00880304434127(17)230319(10)729050 (01)00880304434127(17)230328(10)729040 (01)00880304434127(17)230408(10)960150 (01)00880304434127(17)230816(10)957220 (01)00880304434127(17)240221(10)451540 (01)00880304434127(17)240714(10)299920 (01)00880304434127(17)250319(10)564400 (01)00880304434127(17)250331(10)150450 (01)00880304434127(17)260118(10)770600 (01)00880304433496(17)230816(10)957590 (01)00880304433496(17)240327(10)868620 (01)00880304433496(17)240521(10)537430 (01)00880304433496(17)240612(10)810590", "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": "411 Technical Services\n574-371-3071", "reason_for_recall": "Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.", "root_cause_description": "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. \n\nCustomers 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.\n\nIf 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.\n\nThere are no specific patient monitoring instructions related to this recall that are recommended beyond your existing follow-up schedule.", "product_quantity": "214741", "distribution_pattern": "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.", "openfda": { "k_number": [ "K070565", "K063652", "K231516", "K230831", "K162068", "K191963", "K130126", "K212933", "K032895", "K844415", "K081448", "K140390", "K163397", "K220792", "K233712", "K240876", "K202716", "K083439", "K010635", "K043100", "K231099", "K060692", "K193038", "K251098", "K060716", "K173824", "K011099", "K253592", "K223876", "K183553", "K213856", "K123297", "K250848", "K112905", "K201905", "K011047", "K222427" ], "registration_number": [ "3002579136", "3016851379", "1000200989", "3015806723", "3005497913", "8010379", "1828288", "3035366890", "3003403260", "3013055499", "3008812251", "1825034", "3006801265", "3011015572", "3002806603", "3021008900", "3020967480", "1221934", "3010386387", "3009887475", "3010163695", "3008395353", "1423662", "3015516266", "3003898228", "3006128100", "3017397663", "9681465", "1450662", "1424263", "3008791302", "3026771806", "1422572", "3004976965", "3015231789", "3006946276", "2528981", "3005180920", "3013791180", "3004748528", "3009475821", "9616944", "3010057495", "1835831", "1835444", "3007993775", "3009417901", "3009546990", "3006017180", "3008534770", "3011683674", "1526534", "2029275", "3014302784", "3014680795", "3013176080", "3012725451", "1064858", "3014315560", "3008021110", "3010178296", "1836116", "1834331", "1822565", "3002806470", "3011274144", "8010916", "3011461101", "3012319330", "1644408", "1529009", "3008868758", "8043792", "3012544635", "3015399803", "3007923096", "3008110533", "3015207155", "3008421730", "1721676", "3010331645", "3015542154", "3008812560", "3004641308", "9616671", "3010173425", "3010009693", "1000517406", "9617840", "3015916578", "3027484613", "3004153896", "2183946", "1834379", "1220246", "1818910", "3007740680" ], "fei_number": [ "3002579136", "3016851379", "1000200989", "3015806723", "3005497913", "1828288", "3035366890", "3003403260", "3008397795", "3013055499", "1000306431", "1825034", "1000116912", "3006801265", "3011015572", "3002806603", "3021008900", "3002808269", "3020967480", "1221934", "3010386387", "3009887475", "3010163695", "3001814066", "3008395353", "3003110073", "3015516266", "3003898228", "3006128100", "3017397663", "1450662", "3008791302", "3026771806", "3002808293", "3004976965", "3000215273", "3002807113", "3003569173", "3015231789", "3006946276", "2528981", "3005180920", "3013791180", "3004748528", "3009475821", "3010057495", "3003714383", "3007993775", "3009417901", "3009546990", "3006017180", "3008534770", "3011683674", "1526534", "1000306340", "3014302784", "3014680795", "3013176080", "3012725451", "3014315560", "3008021110", "3002854251", "3002806470", "3011274144", "3011461101", "1000220336", "1000306303", "3012319330", "1000116116", "3002807036", "3008868758", "3012544635", "3003015552", "1000149660", "1000199976", "3000717687", "3015399803", "3007923096", "3008110533", "3015207155", "3008421730", "1721676", "3010331645", "3015542154", "3008812560", "3004641308", "1000220733", "3010009693", "1000517406", "3015916578", "3027484613", "3004153896", "3002687954", "1220246", "1818910", "3003414678", "3007740680" ], "device_name": "Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented", "medical_specialty_description": "Orthopedic", "regulation_number": "888.3670", "device_class": "2" } } ] }