{ "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": "150760", "product_res_number": "Z-0650-2017", "event_date_initiated": "2016-10-25", "event_date_posted": "2016-11-21", "recall_status": "Terminated", "event_date_terminated": "2017-06-06", "res_event_number": "75540", "product_code": "MEH", "k_numbers": [ "K150862" ], "product_description": "ACTIS Flex Reamers SZ 0/1; 2/3; 4/5; 6/7; 8/9; 10/11; 12, Product is sold non-sterile, these instruments are packed non-sterile, within a rigid tube with foam protectors, with label and IFU", "code_info": "Product Codes: 201001210, ACTIS FLEX REAMER SZ 0/1, GTIN: 10603295434818; 201001220, ACTIS FLEX REAMER SZ 2/3, GTIN: 10603295434870; 201001230, ACTIS FLEX REAMER SZ 4/5, GTIN: 10603295434849; 201001240, ACTIS FLEX REAMER SZ 6/7, GTIN: 10603295434856; 201001250, ACTIS FLEX REAMER SZ 8/9, GTIN: 10603295434863; 201001260, ACTIS FLEX REAMER SZ 10/11, GTIN: 10603295434825; 201001270, ACTIS FLEX REAMER SZ 12, GTIN: 10603295434832", "firm_fei_number": "1818910", "recalling_firm": "Depuy Orthopaedics Inc.", "address_1": "700 Orthopaedic Dr", "city": "Warsaw", "state": "IN", "postal_code": "46582-3994", "additional_info_contact": "Kim Earle, M.S.\n574-371-4917", "reason_for_recall": "DePuy Orthopaedics, Inc. is issuing a voluntary recall for all lots of the ACTIS Flex Reamers due to the instruments breaking and potentially leaving pieces in the patient.", "root_cause_description": "Under Investigation by firm", "action": "Depuy Orthopaedics initiated a recall on October 25, 2016. Notices were sent to the US Distributors via email on October 25, 2016. \n\nCustomers were instructed to do the following: 1. Immediately Inspect Inventory, 2. Immediately Return US Distributor Inventory: If any affected instruments are found in a US Distributors inventory, return to:\nDePuy Synthes Joint Reconstruction, a division of DePuy Orthopaedics, Inc.\n3. To expedite the return and credit process: Be sure to reference H16-14 on all return paperwork and/or online return forms and on the outside of the box when returning recalled lots of the instrument.\n4. Upon receipt of the affected instruments, affected instruments will be credited against the US Distributors B&R budget.\n5. Within 5-Business Days: Complete the Distributor Card or for the Reconciliation Form: Within 5-business days of initiation, the completed Reconciliation Form should be returned to DePuy Orthopaedics, Inc.\n6. Retain copies of all field action documents in customer files\n\nFor further questions please call (574) 371-4917.", "product_quantity": "137", "distribution_pattern": "US Distribution to the states of: CA, KY, LA, MD, ME, NC, NH, NY, TX, VA, WA\n\nForeign: Austria, Ireland, and Japan\n\nVA/DOD:", "openfda": { "k_number": [ "K023302", "K113320", "K910156", "K993943", "K040680", "K910755", "K951671", "K211703", "K971422", "K242315", "K905781", "K912452", "K896047", "K912654", "K913916", "K020963", "K112091", "K944836", "K993768", "K915350", "K080584", "K081044", "K983382", "K251166", "K181778", "K992815", "K990666", "K955305", "K171273", "K980070", "K112556", "K020615", "K241690", "K951291", "K121627", "K092406", "K000262", "K934729", "K023102", "K946234", "K922621", "K020572", "K013676", "K993077", "K032641", "K162303", "K150855", "K162732", "K153131", "K082892", "K021403", "K071916", "K942891", "K915655", "K964878", "K943957", "K970394", "K945691", "K072020", "K935696", "K251052", 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