{ "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": "189033", "product_res_number": "Z-0122-2022", "event_date_initiated": "2021-07-21", "event_date_created": "2021-10-16", "recall_status": "Open, Classified", "res_event_number": "88585", "product_code": "HXL", "product_description": "MPR Slotted Mallet, labeling etched onto devices as follows: \n\nMedical Products Resource\n800.524.5194\nwww.m-p-r.com\nMPR-1120-1000\n(01)00840001405868", "code_info": "Model Number: MPR-1120-1000, Lot Number: 200911-1-1", "firm_fei_number": "1000139815", "recalling_firm": "Implant Resource Inc", "address_1": "917 Lone Oak Rd Ste 1000 917 Lone Oak Rd", "address_2": "Ste 1000", "city": "Eagan", "state": "MN", "postal_code": "55121-2266", "additional_info_contact": "Ben Hanson\n952-277-1257", "reason_for_recall": "Potential for mallet head to become separated from mallet handle. There is also significant deformations on striking surface that were not expected", "root_cause_description": "Device Design", "action": "Customers were initially contacted via email on 07/21/2021 to initiate the return of affected devices. A formal letter was sent to customers on 09/03/2021 via UPS. Instructions included to review the notification and ensure affected personnel are notified of the recall, immediately locate and quarantine any affected product in inventory, and to immediately return any affected product to Medical Products Resource.", "product_quantity": "6 units", "distribution_pattern": "US distribution to Florida and New Hampshire", "openfda": { "registration_number": [ "3010331645", "3012358417", "3003120897", "8040881", "3039103971", "3004001706", "1416666", "3010065126", "3007539489", "1421879", "3018094310", "3032747418", "3010455030", "3014004349", "3012130008", "1649518", "3010197239", "3007597038", "3015156396", "3031240334", "3031231776", "8043496", "9610612", "9611278", "1932180", "3016050940", "1058726", "9615857", "3009499159", "1000517406", "3012764194", "9614062", "3012447612", "3005440795", "3003644849", "2184171", "9680515", "3019455", "3013503739", "3009540749", "9680619", "3015451162", "2031966", "3004983210", "2132732", "3005641619", "1828464", 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