{ "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": "120669", "product_res_number": "Z-0070-2014", "event_date_initiated": "2013-08-30", "event_date_posted": "2013-10-25", "recall_status": "Terminated", "event_date_terminated": "2014-09-25", "res_event_number": "65799", "product_code": "LPH", "k_numbers": [ "K953337" ], "product_description": "Versys Beaded Fullcoat Femoral Stem\t(POR FULL-CT FEM ST 11X160MM; VERSYS BEADED FC 11X200MM 8ST; POR FULLCT FEM ST 11 LOW EXT; POR FULLCT FEM ST 11 EXT; POR FLCT FEM STEM LM 11X160MM; POR FULLCT LM FEM ST 11 EXT\r\nPOR FULL-CT FEM ST 12X160MM\r\nVERSYS BEADED FC 12X200MM 8 ST \r\nPOR FULLCT FEM ST 12 LOW EXT\r\nPOR FLCT FEM ST 12.0X190 STR\r\nPOR FULLCT FEM ST 12 EXT\r\nPOR FULL-CT FEM ST LM 12X160MM\r\nPOR FULLCT LM FEM ST 12 EXT\r\nPOR FULL-CT FEM ST 13X160MM\r\nVERSYS HIP SYSTEM REVISION FEMORAL BEADED FULLCOAT PLUS COLL \r\nPOR FULLCT FEM ST 13 LOW EXT\r\nPOR FLCT FEM ST 13.5X190 STR\r\nPOR FULLCT FEM ST 13 EXT\r\nPOR FULL-CT FEM ST LM 13X160MM\r\nPOR FULLCT LM FEM ST 13 EXT\r\nPOR FULL-CT FEM ST 14X160MM\r\nVERSYS BEADED FC 14X200MM 8 ST \r\nPOR FULLCT FEM ST 14 LOW EXT\r\nPOR FULLCT FEM ST 14 EXT\r\nPOR FULL-CT FEM ST LM 14X160MM\r\nPOR FULLCT LM FEM ST 14 EXT\r\nPOR FULL-CT FEM ST 15X160MM\r\nVERSYS BEADED FC 15X200MM 8 ST \r\nPOR FULLCT FEM ST 15 LOW EXT\r\nPOR FLCT FEM ST 15.0X190 STR\r\nPOR FLCT FEM ST 15.0X250 STR\r\nPOR FULLCT FEM ST 15 EXT\r\nPOR FULL-CT FEM ST LM 15X160MM\r\nPOR FULLCT FEM ST 15 XEXT\r\nPOR FULLCT LM FEM ST 15 EXT\r\nPOR FULL-CT FEM ST 16X160MM\r\nVERSYS BEADED FC 16X200MM 8 ST \r\nPOR FULLCT FEM ST 16 LOW EXT\r\nPOR FLCT FEM ST 16.5X190 STR\r\nPOR FLCT FEM ST 16.5X250 STR\r\nPOR FULLCT FEM ST 16 EXT\r\nPOR FULL-CT FEM ST LM 16X160MM\r\nPOR FULLCT FEM ST 16 XEXT\r\nPOR FULLCT LM FEM ST 16 EXT\r\nPOR FULL-CT FEM ST 17X160MM\r\nVERSYS BEADED FC 17X200MM 8 ST \r\nPOR FULLCT FEM ST 17 EXT\r\nPOR FULL-CT FEM ST LM 17X160MM\r\nPOR FULLCT FEM ST 17 XEXT\r\nPOR FULLCT LM FEM ST 17 EXT\r\nPOR FULL-CT FEM ST 18X160MM\r\nVERSYS BEADED FC 18X200MM 8 ST \r\nPOR FLCT FEM ST 18.0X190 STR\r\nPOR FLCT FEM ST 18.0X250 STR\r\nPOR FULLCT FEM ST 18 EXT\r\nPOR FULL-CT FEM ST LM 18X160MM\r\nPOR FULLCT FEM ST 18 XEXT\r\nPOR FULLCT LM FEM ST 18 EXT\r\nPOR FULL-CT FEM ST 19X160MM\r\nPOR FLCT FEM ST 19.5X190 STR\r\nPOR FLCT FEM ST 19.5X250 STR\r\nPOR FULLCT FEM ST 19 EXT\r\nPOR FLCT FEM STEM LM 19X160MM\r\nPOR FULLCT FEM ST 19 XEXT\r\nPOR FULLCT LM FEM ST 19 EXT\r\nPOR FULL-CT FEM ST 20X160MM\r\nVERSYS BEADED FC 20X200MM 8 ST \r\nPOR FULLCT FEM ST 20 EXT\r\nPOR FLCT FEM STEM LM 20X160MM\r\nPOR FULLCT FEM ST 20 XEXT\r\nPOR FULLCT LM FEM ST 20 EXT\r\nPOR FULL-CT FEM ST 21X160MM\r\nPOR FLCT FEM ST 21.0X190 STR\r\nPOR FLCT FEM ST 21.0X250 STR\r\nPOR FULLCT FEM ST 21 EXT\r\nPOR FLCT FEM STEM LM 21X160MM\r\nPOR FULLCT FEM ST 21 XEXT\r\nPOR FULLCT LM FEM ST 21 EXT\r\nPOR FULLCT FEM STEM 22X160MM\r\nPOR FLCT FEM ST 22.5X190 STR\r\nPOR FLCT FEM ST 22.5X250 STR\r\nPOR FULLCT FEM ST 22 EXT\r\nPOR FLCT FEM STEM LM 22X160MM\r\nPOR FULLCT FEM ST 22 XEXT\r\nPOR FULLCT LM FEM ST 22 EXT.\r\n\r\nUsed in total hip replacement.", "code_info": "Part Number Range: 00-7843-011/022-06/56", "firm_fei_number": "1000220733", "recalling_firm": "Zimmer, Inc.", "address_1": "345 E Main St", "city": "Warsaw", "state": "IN", "postal_code": "46580-2746", "additional_info_contact": "800-613-6131", "reason_for_recall": "The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.", "root_cause_description": "Package design/selection", "action": "August 30, 2013 Urgent Recall Notices were sent to Distributors, hospital risk managers and surgeons identifying the issue and directing consignees to make all affected personnel aware of the contents of the notification. The notice identified the products involved, the issue, possible adverse events associated with the issue and recommended that implants found with LDPE bag adhesion not use the product and return it to Zimmer sales representatives. Questions or concerns should be addressed to Zimmer customer call center at 1-877-946-2761 between the hours of 8 a.m. and 5 p.m. EST.", "product_quantity": "6380", "distribution_pattern": "Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Germany, Guatemala, Honduras, Hong Kong, India, Israel, Jamaica, Japan, Korea, Malaysia, Mexico, New Zealand, Nicaragua, Panama, Peru, Singapore, Taiwan, Thailand, and Venezula.", "openfda": { "k_number": [ "K963309", "K101761", "K251833", "K970300", "K953694", "K971020", "K103384", "K163193", "K010170", "K002960", "K132572", "K042252", "K852198", "K200656", "K200391", "K172684", "K974506", "K041109", "K102399", "K964769", "K072154", "K041950", "K100933", "K220468", "K010282", "K935875", "K953664", "K192450", "K070278", "K953490", "K000538", "K971429", "K191936", "K000321", "K061547", "K061226", "K991485", "K963101", 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"3013791180", "3013450937", "3004638532" ], "device_name": "Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented", "medical_specialty_description": "Orthopedic", "regulation_number": "888.3358", "device_class": "2" } } ] }