{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "114765", "product_res_number": "Z-0830-2013", "event_date_initiated": "2013-01-04", "event_date_posted": "2013-02-15", "recall_status": "Terminated", "event_date_terminated": "2014-05-20", "res_event_number": "63783", "product_code": "MBH", "k_numbers": [ "K071417" ], "product_description": "LPS Diaphyseal Sleeves\r\n\r\nProduct Usage:\r\nThe LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee product that allows surgeons to reconstruct severe soft tissue and bony defects.", "code_info": "Part number: 198720024 and Lot numbers: 113812, 123509, 140578, 156210, 171659, 171660, 171661, 171662, 171663, 123509A, B34GE1000, B34GEA000, B4EGR1000, B4EGRA000, B4EGRB000, B4XFL1000, B4XFLA000, B5SH11000, B5SH1A000, B5SH1B, C74J11000, D14KG1000, E4RF21000, EN8CY1000, EN8CYA000, FC1MB1, and FC1MBA.", "firm_fei_number": "1818910", "recalling_firm": "DePuy Orthopaedics, Inc.", "address_1": "700 Orthopaedic Dr", "city": "Warsaw", "state": "IN", "postal_code": "46582-3994", "additional_info_contact": "Mindy Tinsley\n574-267-8143", "reason_for_recall": "DePuy Orthopaedics is initiating a voluntary recall of the LPS Diaphyseal sleeve because the product has the potential for fracture at the taper junction. The LPS Diaphyseal Sleeve to Diaphyseal Sleeve Base taper connection may not be sufficient to accommodate potential physiologic loads that may be transferred to the junction during normal gait activities by some patients.", "root_cause_description": "Device Design", "action": "DePuy Othopaedics sent an Urgent Information Medical Device Recall Notice letter dated January 4, 2013 to all affected customers. The letter identified the affected products, reason for recall, clinical implications and actions to be taken. The letter instructed customers to check inventory, discontinue use, cease further distribution and return all inventory on hand for credit. Customers were requested to complete and return the Reconciliation Form. For product-related questions contact your local DePuy Othopaedics Sales Representative, clinical questions contact DePuy's Scientific Information Office at 1-888-554-2482 and recall notice information call 574-372-7333.", "product_quantity": "162 total units (US) and 102 units total (OUS)", "distribution_pattern": "Worldwide Distribution - US Nationwide in the states of AL, AZ, CA, CO, FL, GA, ID, IL, MA, MD, MI, MN, NC, NM, NV, NY, OH, PA, SC, SD, TN, TX, VA, WA, WI, and WV and the countries of Holland, Australia, Austria, South Africa and Canada including Veteran Administration hospitals.", "openfda": { "k_number": [ "K043083", "K251840", "K091543", "K250980", "K050222", "K211246", "K140302", "K051510", "K213817", "K043374", "K150832", "K031061", "K243247", "K243768", "K141407", "K181794", "K223316", "K232303", "K170288", "K241597", "K233507", "K102927", "K140257", "K031462", "K153586", "K141635", "K063731", "K141840", "K132873", "K203779", "K053340", "K140881", "K253189", 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