{ "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": "2026-04-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "country": "United States", "city": "Mercedita", "address_1": "Turpeaux Industrial Park Rd 1 km 123.4", "reason_for_recall": "As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.", "address_2": "", "product_quantity": "3500", "code_info": "lot no.: 61982436 61867365 61886667 61886668 61820722 61897702 61977095 61799436 61934575 61828057 61982437 61828048 61934576 61798403 61906719 62031688 62197641 61663372 61828049 61886669 61828050 62031689 61828053 62106374 61828054 62033051 62197643 61828055 61906715 61982438 61867334 61977096 61927725 61784953 61867368 61849821 61849827 61906712 62124274 62120943 61785930 61771006 61826981 61895080 61902197 61827363 61888704 61895083 62255904 61902213 61990124 61753044 62271887 61850459 61778818 61778840 61827350 61827352 61827355 61853069 61865454 61865455 61888705 61895087 61897708 61897709 61897711 61900062 61941016 61941017 61958817 61990133 62127925 62130793 62130794 62241680 62255912 62255914 62255920 62271894 61902217 61958146 62271889 61958147 61955869 62105421 61860644 61888706 61937605 370531 61853081 61870427 62230186 61777469 61923868 61940612 61940613 370989 61853082 61955870 61890945 61930189 61859417 61923869 61788809 61829108 370516 61860640 61874946 370515 370959 370956 61843251 61937601 62105422 371015 61895079 61788813 61849271 371014 370517 61860668 61869716 61874978 370990 370923 61891507 371071 61902208 370955", "center_classification_date": "20160312", "distribution_pattern": "US Nationwide Distribution", "state": "PR", "product_description": "Product 30 consists of all product under product code: KTT and same usage: Item no:\t 118100527\tFREE-LOCK LAG SCREW, 12.7 118100535\tFREE-LOCK LAG SCREW, 12.7 118100540\tFREE-LOCK LAG SCREW, 12.7 118100542\tFREE-LOCK LAG SCREW, 12.7 118101022\tFREE-LOCK LAG SCREW, 12.7 118101025\tFREE-LOCK LAG SCREW, 12.7 118101027\tFREE-LOCK LAG SCREW, 12.7 118101030\tFREE-LOCK LAG SCREW, 12.7 118101032\tFREE-LOCK LAG SCREW, 12.7 118101035\tFREE-LOCK LAG SCREW, 12.7 118101037\tFREE-LOCK LAG SCREW, 12.7 118101040\tFREE-LOCK LAG SCREW, 12.7 118101042\tFREE-LOCK LAG SCREW, 12.7 118101045\tFREE-LOCK LAG SCREW, 12.7 118101047\tFREE-LOCK LAG SCREW, 12.7 118101052\tFREE-LOCK LAG SCREW, 12.7 118101055\tFREE-LOCK LAG SCREW, 12.7 118101057\tFREE-LOCK LAG SCREW, 12.7 118101522\tFREE-LOCK LAG SCREW, 15.8 118101525\tFREE-LOCK LAG SCREW, 15.8 118101527\tFREE-LOCK LAG SCREW, 15.8 118101530\tFREE-LOCK LAG SCREW, 15.8 118101532\tFREE-LOCK LAG SCREW, 15.8 118101547\tFREE-LOCK LAG SCREW, 15.8 118109010\tFREE-LOCK SUPRACOND TUBE/ 118109510\tFREE-LOCK SUPRACOND TUBE/ 118113005\tFREE-LOCK TUBE & SCP PLAT 118113006\tFREE-LOCK TUBE & SCP PLAT 118113010\tFREE-LOCK TUBE & SCP PLAT 118113504\tFREE-LOCK TUBE & SCP PLAT 118113505\tFREE-LOCK TUBE & SCP PLAT 118113506\tFREE-LOCK TUBE & SCP PLAT 118113508\tFREE-LOCK TUBE & SCP PLAT 118113510\tFREE-LOCK TUBE & SCP PLAT 118113594\tFREE-LOCK TUBE & SCP PLAT 118114005\tFREE-LOCK TUBE & SCP PLAT 118114006\tFREE-LOCK TUBE & SCP PLAT 118114008\tFREE-LOCK TUBE & SCP PLAT 118114010\tFREE-LOCK TUBE & SCP PLAT 118114012\tFREE-LOCK TUBE & SCP PLAT 118114004\tFREE-LOCK TUBE & SCP PLAT 118114008\tFREE-LOCK TUBE & SCP PLAT 118114010\tFREE-LOCK TUBE & SCP PLAT 118114012\tFREE-LOCK TUBE & SCP PLAT 118114504\tFREE-LOCK TUBE & SCP PLAT 118114505\tFREE-LOCK TUBE & SCP PLAT 118114506\tFREE-LOCK TUBE & SCP PLAT 118114508\tFREE-LOCK TUBE & SCP PLAT 118114512\tFREE-LOCK TUBE & SCP PLAT 118114594\tFREE-LOCK TUBE & SCP PLAT 118114508\tFREE-LOCK TUBE & SCP PLAT 118114512\tFREE-LOCK TUBE & SCP PLAT 118114594\tFREE-LOCK TUBE & SCP PLAT 118115004\tFREE-LOCK TUBE & SCP PLAT 118115005\tFREE-LOCK TUBE & SCP PLAT 118115006\tFREE-LOCK TUBE & SCP PLAT 118115008\tFREE-LOCK TUBE & SCP PLAT 118115094\tFREE-LOCK TUBE & SCP PLAT 118113508\tFREE-LOCK TUBE & SCP PLAT 118113506\tFREE-LOCK TUBE & SCP PLAT 118113505\tFREE-LOCK TUBE & SCP PLAT 118113504\tFREE-LOCK TUBE & SCP PLAT 118113004\tFREE-LOCK TUBE & SCP PLAT Product Usage: Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.", "report_date": "20160323", "classification": "Class II", "openfda": {}, "recalling_firm": "Zimmer Manufacturing B.V.", "recall_number": "Z-1128-2016", "initial_firm_notification": "Letter", "product_type": "Devices", "event_id": "72900", "termination_date": "20170413", "more_code_info": "", "recall_initiation_date": "20160111", "postal_code": "00715", "voluntary_mandated": "Voluntary: Firm initiated", "status": "Terminated" } ] }