{ "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": 8 } }, "results": [ { "cfres_id": "30126", "product_res_number": "Z-0154-04", "event_date_initiated": "2003-10-14", "event_date_posted": "2004-07-20", "recall_status": "Terminated", "event_date_terminated": "2004-08-03", "res_event_number": "27578", "product_code": "EFB", "k_numbers": [ "K963050" ], "product_description": "Midwest Tradition PB Non-Fiber Optic High Speed Handpiece with Push Button Chuck (4 tube connection), catalog #790044; Manufactured for DENTSPLY Professional, A Division of DENTSPLY International, 901 West Oakton Street, Des plaines, IL 60018-1884 USA", "code_info": "Chuck manufacturing lot numbers 7/15/03, 7/25/03, 8/12/03, 8/14/03; handpiece serial numbers 52038725 through 52429358. Not all units in the serial number range were affected. 230 units were sold new with affected chucks and 259 units were repaired with the affected chucks.", "firm_fei_number": "1419322", "recalling_firm": "DentSply -Professional Division", "address_1": "901 W Oakton St", "city": "Des Plaines", "state": "IL", "postal_code": "60018-1843", "additional_info_contact": "DENTSPLY Professional Customer Service\n800-800-2888", "reason_for_recall": "Small cracks in the dental handpiece's chuck could allow the dental burs to drift out of the chuck over time.", "root_cause_description": "Other", "action": "Dealers were telephoned on 10/14-16/03 and sent follow-up faxed letters on the same dates. The dealers were informed of the potential for cracked bur chucking mechanisms in the handpieces, requested to examine their stocks for the affected serial numbers, using the faxed list of serial numbers shipped to each account, and return the affected handpieces to DENTSPLY via FedEx. The dealers were also requested to verify the serial number list to those handpieces shipped to customers. If the affected serial numbers were distributed, the customer was requested to supply a list of those customers with contact information to DENTSPLY. As those lists are received by DENTSPLY, end user letters are sent to those customers, informing them of the problem with the bur chucking mechanism and requesting the retutrn of the affected serial numbers for examination and replacement of the bur chucking mechanism if necessary.", "product_quantity": "489 units", "distribution_pattern": "Nationwide, Canada and Mexico", "openfda": { "k_number": [ "K790113", "K905541", "K052822", "K170261", "K925378", "K202371", "K944710", "K944708", "K171174", "K900093", "K000710", "K130560", "K944715", "K962877", "K192412", "K885115", "K051872", "K132478", "K251389", "K963843", "K172543", "K821715", "K143704", "K022119", "K923780", "K202674", "K143183", "K954991", "K792302", "K981679", "K072754", "K062947", "K882491", "K925739", "K944711", "K944716", "K233308", "K112024", "K173465", "K882135", "K240337", "K900798", "K863677", "K981869", "K071561", "K982050", "K241074", "K850597", "K971774", "K972376", "K112673", "K896878", "K090548", "K151912", 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