{ "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": "2026-04-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "status": "Terminated", "city": "Warsaw", "state": "IN", "country": "United States", "classification": "Class II", "openfda": {}, "product_type": "Devices", "event_id": "73142", "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": "Worldwide Distribution - US (nationwide) and Internationally to ARGENTINA AUSTRALIA AUSTRIA BARBADOS BELGIUM BERMUDA BOLIVIA BRAZIL CARIBBEAN CHILE CHINA COLOMBIA COST RICA DENMARK DOMINICAN REPUBLIC DORAL FL ECUADOR EL SALVADOR ENGLAND FRANCE GERMANY GUATEMALA HONDURAS HONG KONG INDIA ISRAEL ITALY JAMAICA JAPAN KOREA MALAYSIA MEXICO NEW ZEALAND NICARAGUA PANAMA PERU SINGAPORE SPAIN SWEDEN SWITZERLAND TAIWAN THAILAND VENEZUELA WEST INDIES Canary Islands Croatia Cyprus Czech Republic Canada", "recall_number": "Z-0833-2016", "product_description": "NexGen Knee CR Porous FEM NexGen Knee CR Precoat FEM prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer various sizes \"\" This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collagen disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. \" CR and LPS porous coated femoral and tibial baseplate components may be used cemented or uncemented (biological fixation). The CR Hydroxyapatite/tricalcium phosphate [HA/TCP] coated femoral or tibial baseplate components may only be used uncemented. All other femoral, tibial baseplate and all-polyethylene patella components are indicated for cemented use only.\"", "product_quantity": "18093", "reason_for_recall": "LDPE bag containing the implant adheres to the highly polished implant surface.", "recall_initiation_date": "20160111", "center_classification_date": "20160222", "termination_date": "20170523", "report_date": "20160302", "code_info": "Item numbers: 00-5970-011-31 00-5970-011-32 00-5970-012-31 00-5970-012-32 00-5970-013-31 00-5970-013-32 00-5970-013-33 00-5970-013-34 00-5970-014-31 00-5970-014-32 00-5970-014-33 00-5970-014-34 00-5970-015-31 00-5970-015-32 00-5970-015-33 00-5970-015-34 00-5970-016-31 00-5970-016-32 00-5970-017-31 00-5970-017-32 00-5970-018-31 00-5970-018-32 00-5972-011-31 00-5972-011-32 00-5972-012-31 00-5972-012-32 00-5972-013-33 00-5972-013-34 00-5972-014-33 00-5972-014-34 00-5972-015-33 00-5972-015-34 00-5972-016-31 00-5972-016-32 00-5972-017-31 00-5972-017-32 00-5972-018-31 00-5972-018-32 Lot numbers: 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