{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "198315", "product_res_number": "Z-1208-2023", "event_date_initiated": "2023-01-20", "event_date_posted": "2023-03-02", "recall_status": "Open, Classified", "res_event_number": "91601", "product_code": "EFB", "k_numbers": [ "K071891" ], "product_description": "SciCan STATIS SL S10001 Dental Handpieces-Intended for the removal of carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations, restorations and for polishing teeth.\nModel Number: S10001", "code_info": "UDI-DI: +ESANS100010\n\nAll Serial Numbers", "firm_fei_number": "2416455", "recalling_firm": "Coltene Whaledent Inc", "address_1": "235 Ascot Pkwy", "city": "Cuyahoga Falls", "state": "OH", "postal_code": "44223-3701", "additional_info_contact": "SAME\n330-916-8858", "reason_for_recall": "Screw connection between the turbine head and the push button may loosen and fall off during the treatment, and increase the risk of swallowing or inhaling part of the turbines head or the push button", "root_cause_description": "Other", "action": "Coltene issued Urgent Medical Device Correction to Distributors. The written notification included the Field Safety Notice issued by the manufacturer and the Correction Notice that was issued on January 20th, 202 via Email. Letter states reason for notification, health risk, and action to take: Warning:\nWhen using the STATIS SL turbines with REF 2.000.7300 / S10001, with the lack of care or age-related wear and tear, there is a possibility that the push button on the turbine will come loose and this will increase the risk of swallowing or inhaling part of the turbines head or the push button.\nRecommended action for users:\nPlease urgently observe the following safety instructions from the instructions for use on handling, care and running behaviour of the turbine to protect your patients.\n\nThis notice needs to be passed on to all those who need to be aware, both within your own organization and in organizations where the potentially affected devices have been transferred. Please ensure that this information and the associated action are followed for a reasonable period of time to ensure the effectiveness of the action.", "product_quantity": "3896 units", "distribution_pattern": "Nationwide\nForeign:\nCanada\nGermany\nIndonesia\nIreland\nLebanon\nSaudia Arabia\nTurkey", "openfda": { "k_number": [ "K760331", "K863677", "K132478", "K113301", "K113674", "K173943", "K924089", "K000049", "K961235", "K080240", "K073478", "K242179", "K062947", "K112869", "K882135", "K974671", "K955655", "K840690", "K944710", "K042787", "K190508", "K010127", "K181900", "K143704", "K202371", "K790113", "K904671", "K944714", "K241074", "K960541", "K873209", "K935676", "K063110", "K163483", "K111249", "K141576", "K896877", "K112623", "K801651", "K970104", "K172543", "K170261", "K925678", "K120218", "K041141", "K232243", "K070001", "K940261", "K952927", "K052700", "K102517", "K072989", "K073284", "K012720", "K070074", "K925080", "K780038", "K093971", "K801535", "K171553", "K093341", 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