{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "64356", "product_res_number": "Z-0072-2008", "event_date_initiated": "2007-08-30", "event_date_posted": "2007-10-25", "recall_status": "Terminated", "event_date_terminated": "2008-09-05", "res_event_number": "44780", "product_code": "MEH", "k_numbers": [ "K983382" ], "product_description": "Trident PSL HA Cluster Acetabular Shell;\nArc Deposited HA Coated Cluster Screw Holes. Hip prosthesis component. \nHowmedica Osteonics Corp.\n325 Corporate Drive;\nMahwah, NJ 07430;\nA subsidiary of Stryker Corp.\nSterile, Made in USA.", "code_info": "Catalog # Description Lot code 542-11-46D\tTRIDENT PSL HA CLUSTER 46mm R3YMHD; 542-11-48D\tTRIDENT PSL HA CLUSTER 48mm\t1PMMJD 542-11-48D\tTRIDENT PSL HA CLUSTER 48mm\t663MJD 542-11-48D\tTRIDENT PSL HA CLUSTER 48mm\t664MJD 542-11-50E\tTRIDENT PSL HA CLUSTER 50mm\t1TEMJD 542-11-50E\tTRIDENT PSL HA CLUSTER 50mm\t1TJMJD 542-11-50E\tTRIDENT PSL HA CLUSTER 50mm\t2K0MJD 542-11-50E\tTRIDENT PSL HA CLUSTER 50mm\t32JMJD 542-11-50E\tTRIDENT PSL HA CLUSTER 50mm\t61YMJD 542-11-50E\tTRIDENT PSL HA CLUSTER 50mm\t626MJD 542-11-50E\tTRIDENT PSL HA CLUSTER 50mm\t70HMJD 542-11-50E\tTRIDENT PSL HA CLUSTER 50mm\t71NMJD 542-11-50E\tTRIDENT PSL HA CLUSTER 50mm PYNMHD 542-11-50E\tTRIDENT PSL HA CLUSTER 50mm RHVMHD 542-11-50E\tTRIDENT PSL HA CLUSTER 50mm RHXMHD 542-11-52E\tTRIDENT PSL HA CLUSTER 52mm\t8R8MJD 542-11-52E\tTRIDENT PSL HA CLUSTER 52mm\t8RDMJD 542-11-52E\tTRIDENT PSL HA CLUSTER 52mm\tPYVMHD 542-11-52E\tTRIDENT PSL HA CLUSTER 52mm REKMHD 542-11-54F\tTRIDENT PSL HA CLUSTER 54mm\t0YPMJD 542-11-54F\tTRIDENT PSL HA CLUSTER 54mm\t3HAMJD 542-11-54F\tTRIDENT PSL HA CLUSTER 54mm\t500MJD 542-11-54F\tTRIDENT PSL HA CLUSTER 54mm\t76YMJD 542-11-54F\tTRIDENT PSL HA CLUSTER 54mm 7NWMJD 542-11-54F\tTRIDENT PSL HA CLUSTER 54mm\t7Y3MJD 542-11-54F\tTRIDENT PSL HA CLUSTER 54mm\t7Y4MJD 542-11-54F\tTRIDENT PSL HA CLUSTER 54mm 8HWMJD 542-11-54F\tTRIDENT PSL HA CLUSTER 54mm\tTK9MHD 542-11-54F\tTRIDENT PSL HA CLUSTER 54mm\tTKAMHD 542-11-54F\tTRIDENT PSL HA CLUSTER 54mm TKDMHD 542-11-54F\tTRIDENT PSL HA CLUSTER 54mm TKEMHD 542-11-54F\tTRIDENT PSL HA CLUSTER 54mm TKHMHD 542-11-56F\tTRIDENT PSL HA CLUSTER 56mm\t0PJMJD 542-11-56F\tTRIDENT PSL HA CLUSTER 56mm\t0PMMJD 542-11-56F\tTRIDENT PSL HA CLUSTER 56mm\t81AMJD 542-11-56F\tTRIDENT PSL HA CLUSTER 56mm\t81DMJD 542-11-56F\tTRIDENT PSL HA CLUSTER 56mm\tT6KMHD 542-11-58G\tTRIDENT PSL HA CLUSTER 58mm\t518MJD 542-11-62H\tTRIDENT PSL HA CLUSTER 62mm\t2PMMJD 542-11-62H\tTRIDENT PSL HA CLUSTER 62mm\t7D2MJD 542-11-68I\t TRIDENT PSL HA CLUSTER 68mm \t3AWMJD 542-11-72J\t TRIDENT PSL HA CLUSTER 72mm 1WNMJD", "firm_fei_number": "3003070421", "recalling_firm": "Stryker Howmedica Osteonics Corp.", "address_1": "325 Corporate Dr", "city": "Mahwah", "state": "NJ", "postal_code": "07430-2002", "additional_info_contact": "201-831-5000", "reason_for_recall": "Stryker Orthopaedics had identified that specific lots of Trident PSL Acetabular shells may have a dimensional discrepancy. The deviation regarding the difference in wall thickness will increase the gap between the shell and liner on one side and will decrease the gap between shell and liner on the opposing side, resulting in interference.", "root_cause_description": "Process control", "action": "Recall notification letters were sent out on August 30, 2007 with return receipt.", "product_quantity": "142 units", "distribution_pattern": "Product was distributed nationwide and one unit to Brazil.", "openfda": { "k_number": [ "K023302", "K113320", "K910156", "K993943", "K040680", "K910755", "K951671", "K211703", "K971422", "K242315", "K905781", "K912452", "K896047", "K912654", "K913916", "K020963", "K112091", "K944836", "K993768", "K915350", "K080584", "K081044", "K983382", "K251166", "K181778", "K992815", "K990666", "K955305", "K171273", "K980070", "K112556", "K020615", "K241690", "K951291", "K121627", "K092406", "K000262", "K934729", "K023102", "K946234", "K922621", "K020572", "K013676", "K993077", "K032641", 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