{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "167727", "product_res_number": "Z-0399-2019", "event_date_initiated": "2018-09-21", "event_date_created": "2018-11-07", "recall_status": "Terminated", "event_date_terminated": "2020-04-14", "res_event_number": "81185", "product_code": "KWY", "k_numbers": [ "K052990" ], "product_description": "StageOne Hip, Models 431207 & 431209Usage:\n\n\nProduct Usage: The single-use cement spacer molds are sterile disposables made of medical grade silicone with a 316L stainless steel reinforcement stem. They are designed to be filled with polymethylmethacrylate/gentamicin bone cement, or equivalent, by injecting with a dispenser/gun into the mold. After the cement cures, the temporary spacers are to be removed from the molds with the reinforcement remaining as the core of the spacer, and placed into the joint space. The spacers remain in place (180 days or less) until the second stage of the two-stage procedure is performed to implant a conventional hip joint prosthesis.", "code_info": "Item Number 431207 Lot # 705550, UDI - (01)00880304447165(17)270927(10)705550  Item Number 431209  Lot # 705570, UDI - (01)00880304447141(17)270916(10)705570 Lot # 705580, UDI - (01)00880304447141(17)270916(10)705580", "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": "574-372-3071", "reason_for_recall": "There is a potential for comingling of the 43MM and 51 MM molds", "root_cause_description": "Error in labeling", "action": "On September 21, 2018, Zimmer Biomet issued URGENT MEDICAL DEVICE RECALL notices and Return Certification Forms to customers via courier service. \n\nDistributors are encouraged to take the following actions:\n\nReview this notification and ensure that affected team members are aware of the contents.\n2. Immediately locate and quarantine affected product in your inventory.\n3. Immediately return all affected product from your distributorship and from affected hospitals within your territory.\na. Complete the Return Certification Form and send to CorporateQuality.PostMarket@zimmerbiomet.com within three (3) days.\nb. For each return, send a copy of Return Certification Form to CorporateQuality.PostMarket@zimmerbiomet.com.\nc. Include a hardcopy of the Return Certification Form in each carton of your return shipment for immediate processing.\nd. Mark RECALL on the outside of the returned cartons.\nReturn the Additional Accounts form to CorporateQuality.PostMarket@zimmerbiomet.com.\na. Review the list of hospitals included with the email notification sent to your facility, which includes a list of hospitals that have already been notified of this recall.\nb. Identify whether there are any additional hospitals that Zimmer Biomet has not notified and list these accounts on the Additional Accounts form. Please provide the form in Excel format.\nc. If there are no additional accounts to notify, please indicate that there are no additional accounts, or indicate None or NA on the form.\n5. Retain a copy of your Inventory Return Certification and product return forms for your records in the event of a compliance audit of your facility.\n\nRisk Managers are encouraged to take the following actions:\n\nReview this notification and ensure that affected personnel are aware of the contents.\n2. 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", "product_quantity": "72 units", "distribution_pattern": "US Nationwide Distribution in the states of: AZ, FL, MI, OH, VA & WI", "openfda": { "k_number": [ "K152439", "K982812", "K101670", "K905370", "K925420", "K853795", "K132539", "K944132", "K982389", "K953977", "K925536", "K123991", "K823482", "K052990", "K941534", "K842344", "K253357", "K961793", "K100151", "K991990", "K180130", "K873514", "K945518", "K900051", "K833991", "K040947", "K223441", "K980801", "K953510", "K191016", "K023743", "K945793", "K080979", "K926387", "K112019", "K884658", "K970447", "K781735", "K220492", "K062693", "K982447", "K925153", "K010081", "K810062", "K855231", "K872019", "K163081", "K881289", "K823726", "K082468", "K200709", "K791823", "K050966", "K981238", "K833175", "K861105", "K100761", "K191297", "K861566", "K833404", "K080647", "K963885", "K812672", "K013211", "K970284", "K183114", "K940743", "K091967", "K931655", "K243634", "K913632", "K922560", 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"3002806603", "3009106092", "3002806725", "3014763043", "3001278222", "3002459190", "3006017180", "2528981", "3003916006", "3002807310", "3015207155", "3015516266", "3013791180", "3013450937" ], "device_name": "Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented", "medical_specialty_description": "Orthopedic", "regulation_number": "888.3390", "device_class": "2" } } ] }