{ "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": "161382", "product_res_number": "Z-0626-2018", "event_date_initiated": "2017-08-25", "event_date_created": "2018-02-15", "recall_status": "Terminated", "event_date_terminated": "2018-08-16", "res_event_number": "79104", "product_code": "KWY", "k_numbers": [ "K150552" ], "product_description": "G7 DUAL MOBILITY LINER 44MM F\n\nProduct Usage:\nIntended for use in hip arthroplasty cases which involves the removal of the damaged joint and tissues to be replaced with artificial prosthesis. The result of the procedure is to relieve pain and restore a sense of normal function and mobility to the damaged joint.", "code_info": "Item #110024464 Lot# 478340", "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\n574-372-3071", "reason_for_recall": "The affected products are labeled and etched as F-44 mm liners; however, the physical products could potentially be E-42 mm liners.", "root_cause_description": "Mixed-up of materials/components", "action": "On August 30, 2017 an Urgent medical device recall removal notice was mailed to customers identified as \"G7 Dual Mobility Liner\". The recall letter requests the following actions to be taken:\n1. Review this notification and ensure affected team members are aware of the contents.\nCF04107 Rev. 2, Eff. Date: 21 Feb. 2017 Ref. CP04102 Recall Activities Page 2 of 4\nZFA 2017-347\n2. Immediately locate and quarantine affected product in your inventory.\n3. Complete the Certification of Acknowledgement portion of Attachment 1 Inventory Return Certification Form.\na. Return a digital copy to corporate quality.postmarket@zimmerbiomet.com within three (3) days.\n4. Immediately return all affected product from your distributorship and affected hospitals within your territory along with a completed Attachment 1 Inventory Return Certification Form to Zimmer Biomet.\nQuestions or concerns can be directed to Customer Service at 1-574-371-3071", "product_quantity": "8", "distribution_pattern": "US Nationwide Distribution", "openfda": { "k_number": [ "K014072", "K980801", "K944132", "K123991", "K023743", "K781735", "K833404", "K223441", "K982812", "K855231", "K962448", "K925420", "K180130", "K970447", "K091967", "K243634", "K861105", "K003363", "K982389", "K152439", "K940743", "K905370", "K945793", "K112019", "K970284", "K913632", "K931655", "K981238", "K040947", "K893959", "K896266", "K922560", "K925153", "K812672", "K893872", "K963885", "K961793", "K941534", "K833175", "K791823", "K823482", "K934159", "K873514", "K862057", "K131354", "K823726", "K082705", "K143113", "K904383", "K173455", "K953510", "K925536", "K895120", "K192236", "K925897", 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