{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "149124", "product_res_number": "Z-0112-2017", "event_date_initiated": "2016-08-17", "event_date_posted": "2016-10-18", "recall_status": "Terminated", "event_date_terminated": "2017-03-29", "res_event_number": "75018", "product_code": "HWE", "product_description": "Sagittal Blade 18.0X0.97X90MM, Model Number: 6118-097-090\n\nProduct Usage:\nHeavy duty Sagittal Blades are used to cut bone and bone related tissue in a variety of orthopedic procedures. Typical procedures include, total-knee, uni-compartmental knee, hip, shoulder and ankle procedures. These blades can be used with the following handpieces; 4208-000-000 (SYSTEM 5 SAGITTAL SAW) 6208-000-000 (SYSTEM 6 SAG SAW) 6298-000-000 (ES6 SAGITTAL SAW) 7208-000-000 (SYSTEM 7 SAG SAW)", "code_info": "Sagittal Blade 18.0X0.97X90MM, Model Number: 6118-097-090, Lot # 16029017", "firm_fei_number": "1811755", "recalling_firm": "Stryker Instruments Div. of Stryker Corporation", "address_1": "4100 E Milham Ave", "city": "Portage", "state": "MI", "postal_code": "49002-9704", "additional_info_contact": "Kelly Jo Davis\n269-389-2921", "reason_for_recall": "Stryker Instruments is voluntarily recalling the Sagittal Blade 18.0X.97X90MM due to the potential for a sterile barrier breach in the product's packaging.", "root_cause_description": "Packaging", "action": "Stryker Instruments is voluntarily recalling the Sagittal Blade 18.0X.97X90MM, product number 6118-097-090, lot number 16029017, due to a breach in the packaging causing a breach in sterility. There is a potential for a bone or soft tissue infection which may require medical or surgical intervention. Customer notices were issued via certified mail on 08/17/2016. Actions to be taken by the Customer/User:\n1.\tImmediately review this Recall Notification. \n\n2.\tCheck all stock areas and/or operating room storage to determine how many Sagittal Blades from the affected lot (listed above) are at your facility. Quarantine and discontinue use of the recalled Sagittal Blades.\n\n3.\tComplete the enclosed Business Reply Form (BRF) to confirm receipt of this notification and identify how many, if any, affected items are currently in your inventory. Please complete and return the BRF even if customers dont have any affected product on hand. \nNote: Customer signature on the BRF indicates that you received and understand this Notification and have followed the instructions in the Notification.\n\n4.\tIf customers have further distributed this product, please forward the recall letters and the attached BRF to all affected locations. Please indicate each location on the BRF. \n\n5.\tFax the completed BRF to Stryker Instruments Regulatory Department at 866-521-2762, or scan and email a copy to kellyjo.davis@stryker.com.\n\n6.\tIf the BRF for customer facilities indicates that recalled product is currently on hand, a FedEx label will be emailed to you. This shipping label should be used to return recalled product. \n\n7.\tUpon receipt of the recalled product, replacement product will be shipped to customer accounts.\n\nFor questions regarding this recall, please contact Stryker Instruments: Kelly Jo Davis, 269-389-2921, kellyjo.davis@stryker.com", "product_quantity": "225", "distribution_pattern": "US Nationwide in the states of RI, WA, CA, CO, WI,FL, ID, ND, MD,TX\n\n\nForeign: Australia, New Zealand, Netherlands, France, Italy", "openfda": { "k_number": [ "K932261", "K961970", "K946197", "K960852", "K903650", "K871717", "K952543", "K022744", "K955591", "K962215", "K854987", "K921131", "K063688", "K911929", "K874044", "K955098", "K971342", "K931734", "K943589", "K962800", "K935753", "K962022", "K972508", "K970088", "K880150", "K935322", "K945208", "K012676", "K802105", "K973736", "K902447", "K902525", "K944946", "K932918", "K855216", "K792353", "K853489", "K973560", "K760977", "K902332", "K961759", "K864929", "K960720", "K901165", 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"regulation_number": "878.4820", "device_class": "1" } } ] }