{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "141089", "product_res_number": "Z-0235-2016", "event_date_initiated": "2015-10-14", "event_date_created": "2015-11-06", "recall_status": "Terminated", "event_date_terminated": "2016-05-06", "res_event_number": "72456", "product_code": "GFA", "product_description": "SSS Reprocessed Zimmer, Synthes, Stryker and Linvatec Drill Bits and Blades \r\n\r\nSurgical drill bits, blades, burs, chisels, rasps, taps and reamers are specially designed surgical accessories to help the surgeon cut and drill bone and bony structures. Reprocessed surgical accessories are indicated for use in patients requiring surgery involving bone and bony structures.", "code_info": "Item No/Model No: 2108-109, 4125-127-090, 2108-110, 2108-115, 2108-120, 2108-151-001, 2108-152, 2108-158, 2108-182, 2108-218, 310.25, 4118-127-090, 4125-147-090, 4806-110-25, 5071-553, 6118-127-90, 6125-127-090  Lot Code: 3743743, 3750611, 3750630, 3753894, 3761982, 3775827, 3779058, 3779129, 3782549, 3782554, 3782565, 3785624, 3785630, 3785676, 3789092, 3789102, 3794000, 3794085, 3796706, 3796799, 3799827, 3802103", "firm_fei_number": "3009350690", "recalling_firm": "Stryker Sustainability Solutions", "address_1": "1810 W Drake Dr", "city": "Tempe", "state": "AZ", "postal_code": "85283-4327", "additional_info_contact": "Chelsea Cullen\n888-888-3433", "reason_for_recall": "It was reported that packaging was not properly sealed.", "root_cause_description": "Employee error", "action": "Stryker sent an Urgent Medical Device Recall letter dated October 14, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.\r\n\r\nThe firm's letter states that the use of the affected lots of the recalled product should be discontinued. Other bit and/or blade lots reprocessed by Stryker Sustainability Solutions should be considered as alternatives. A Recall Effectiveness Check Form including the quantity of affected devices shipped is enclosed.\r\n\r\nThe letter states to complete the Recall Effectiveness Check Form and indicate if any devices from the affected lots remain in inventory. The form needs to be completed even if no affected product is found.\r\n\r\nReturn the completed and signed form to the local Stryker Sustainability Sales Representative or email to to SSSPFA@stryker.com\r\n\r\nIf the form indicates that affected devices remain in inventory, a prepaid shipping\r\nlabel will be issued for the return of the product. Customers will receive a credit for\r\nall affected devices returned. For further questions, please call (888) 888-3433.", "product_quantity": "1202", "distribution_pattern": "US ( nationwide) Distribution to the states of : MN, OH, CA, IN, WI, FL, GA, MO, IA, MT, LA, KS, TX, TN, WY, MD, NJ, WA, PA, SC, NY, MI, AT, HI, MN, AR, AZ, IL, IA, KY, MS, UT, NC, VA, CO, ME and ID., Internationally to Canada.", "openfda": { "k_number": [ "K924953", "K955229", "K854192", "K931769", "K931210", "K861876", "K851880", "K940501", "K934603", "K935391", "K934390", "K802838", "K821487", "K950403", "K810045", "K863788", "K954483", "K820601", "K831714", "K811506", "K933298", "K830434", "K971978", "K953012", "K912761", "K933595", "K896280" ], "registration_number": [ "3010331645", "3024787345", "1038671", "3008812251", "", "3030733800", "3011024991", "3010594904", "3015967359", "1644408", "3012494290", "1220477", "1051526", "8030965", "1421879", "3032747418", "3008787426", "3014004349", "3012130008", "8043971", "1649518", "3009732568", "3031240334", "1450662", "3011944170", 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"1" } } ] }