{ "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-0840-2016", "product_description": "CR Flex GSF Porous Femoral LPS Flex GSF Porous Femoral LPS Flex Porous Femoral prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, 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. \" The CR-Flex GSF and LPS-Flex GSF uncoated (Option) and precoat styles are intended for cemented use only. \" The CR-Flex GSF and LPS-Flex GSF porous coated femoral components may be used cemented or uncemented (biological fixation). \" Specific uses with CR-Flex GSF or LPS-Flex GSF femorals: Provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range. The CR-Flex GSF femoral, when used with 90-prefix NexGen CR articular surfaces, 00-prefix 10, 12 or 14 mm or 90-prefix 17 or 20 mm Prolong¿ Highly Crosslinked Polyethylene CR articular surfaces, or with Gender Solutions Natural-Knee Flex Congruent articular surfaces, is designed for use with a functional posterior cruciate ligament and when load bearing range of motion (ROM) is expected to be less than or equal to 155 degrees. The LPS-Flex GSF femoral, when used with LPS-Flex articular surfaces, is designed for use with both cruciate ligaments excised and when load bearing ROM is expected to be less than or equal to 155 degrees.\"", "product_quantity": "18482", "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: 00-5752-013-01 00-5752-013-02 00-5752-013-05 00-5752-013-06 00-5752-014-01 00-5752-014-02 00-5752-014-05 00-5752-014-06 00-5752-015-01 00-5752-015-02 00-5752-015-05 00-5752-015-06 00-5752-016-01 00-5752-016-02 00-5752-016-05 00-5752-016-06 00-5752-017-01 00-5752-017-02 00-5752-017-05 00-5752-017-06 00-5762-013-51 00-5762-013-52 00-5762-014-51 00-5762-014-52 00-5762-015-51 00-5762-015-52 00-5762-016-51 00-5762-016-52 00-5762-017-51 00-5762-017-52 00-5962-012-51 00-5962-012-52 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