{ "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": "149317", "product_res_number": "Z-0060-2017", "event_date_initiated": "2016-08-18", "event_date_posted": "2016-10-07", "recall_status": "Terminated", "event_date_terminated": "2018-08-01", "res_event_number": "75077", "product_code": "HWA", "k_numbers": [ "K153345" ], "product_description": "Stryker Orthopaedics Universal Acetabular Cup Positioner/Impactor, REF 2101-0200, Non-Sterile, Howmedica Osteonics Corp., Mahwah, NJ, USA, A Subsidiary of Stryker Corp.", "code_info": "Catalog No: 2101-0200, Lot Nos. 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The letter identified the product the problem and the action needed to be taken by the customer.\n\nActions Needed:\n \n1. Please inform users of this Urgent Medical Device Recall and forward this notice to all those individuals who need to be aware within your organization.\n2. Branches/Agencies: Return all affected products available at your location to\nStryker C/0 Stericycle\n3. Hospitals/Branches: Complete and sign the enclosed Business Reply Form and fax a copy to 877-546-0444 or email to Stericycle strvkerortho6536@stericycle.com.\n\n \nOur records indicate that you have received the above referenced instrument. It is our responsibility to ensure that customers who may have received this affected instrument also receive this important communication. Please assist us in meeting our regulatory obligation by faxing back the attached Business Reply Form within 5 days.\n\n\nWe regret any inconvenience this action may cause you and if you have any questions, feel free to contact me at (201) 831-6693.\n\nFor further questions regarding this recall, please call (201) 831-5000.", "product_quantity": "3,768 units", "distribution_pattern": "US and Internationally", "openfda": { "k_number": [ "K841627", "K864422", "K933527", "K770205" ], "registration_number": [ "", "1038671", "3003120897", "3009973699", "3023449169", "3008544874", "1644408", "3020155054", "3012755988", "3010065126", "9614986", "1833053", "3010141347", "1051526", "3013055499", "3007539489", "1421879", "3007410669", "3018094310", "3008021110", "3012130008", "3015542154", "3031240334", "3009158523", "8044098", "3007420745", "3019356409", "3000931034", "3003639920", "9611278", "3016050940", "3002949614", "3005144609", "1224360", "2027487", "3013912820", "1000517406", 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"3004216008", "3010123256", "3006076154", "3003414678", "3012120772", "1000115048", "3013194153", "1000402972", "3010287737", "3004142400", "3009513193", "3005874553", "1000199976", "3033536312", "3004176895", "3008599177", "3008812560", "3003477135", "3005273623", "3009546990", "3009165919", "3009971621", "3012329926", "3010986197", "1000115331", "3009173317", "1000306694", "3009888740", "3025603301", "3003386935", "3011274144", "3007648354", "3036756245", "3000717902", "3008770252", "1828288", "3005596514", "1043534", "1000477302", "1000116912", "1818910", "3008850074", "3000215205", "3035366890", "3014662844", "3008114965", "3006563559", "3045494402", "4476", "3006509795", "3006128100", "2183449" ], "device_name": "Impactor", "medical_specialty_description": "Orthopedic", "regulation_number": "888.4540", "device_class": "1" } } ] }